At first discharge Duration Swelling Redness Pain HISTORY Change over the time.
pain or swelling occurs
19
HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 500- menthol usp, 4% gel HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 500- pain relief gel gel HARMONY HEMP FLEXIBLE PAIN RELIEF LOTION500- menthol usp, 4% lotion HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 1000- menthol usp, 4% gel HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 1000- menthol usp, 4% gel Abacus Health Products, Inc. Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies. ---------- Flexible Pain Relief Line For NDC 73096-071 Harmony Hemp Flexible Pain Relief Lotion 500 Harmony Hemp Flexible Pain Relief Lotion Menthol 4% Joint & Muscle CBD Moisturizing Oil 500mg per bottle Net Wt 8 oz (226.7 g) Menthol USP, 4% Menthol USP, 4%.....................Topical analgesic temporarily relieves minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains For external use only When using this product use only as directed do not bandage tightly or use with a heating pad avoid contact with eyes and mucous membranes do not apply to wounds or damaged, broken or irritated skin a transient burning sensation may occur upon application but generally disappears in several days if severe burning sensation occurs, discontinue use immediately do not expose the area treated with product to heat or direct sunlight. Stop use and ask a doctor if condition worsens blistering or burning occurs pain or swelling occurs
Transcript of pain or swelling occurs
HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 500- menthol usp, 4% gel HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 500- pain relief gel gel HARMONY HEMP FLEXIBLE PAIN RELIEF LOTION500- menthol usp, 4% lotion HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 1000- menthol usp, 4% gel HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 1000- menthol usp, 4% gel Abacus Health Products, Inc.Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they maybe marketed if they comply with applicable regulations and policies. FDA has notevaluated whether this product complies.
----------Flexible Pain Relief Line
For NDC 73096-071 Harmony Hemp Flexible Pain Relief Lotion 500Harmony HempFlexiblePain Relief LotionMenthol 4%Joint & MuscleCBD Moisturizing Oil500mg per bottleNet Wt 8 oz (226.7 g)Menthol USP, 4%Menthol USP, 4%.....................Topical analgesictemporarily relieves minor aches and pain of muscles and joints associated with simplebackache, arthritis, strains, bruises and sprainsFor external use onlyWhen using this product
use only as directeddo not bandage tightly or use with a heating padavoid contact with eyes and mucous membranesdo not apply to wounds or damaged, broken or irritated skina transient burning sensation may occur upon application but generally disappears inseveral daysif severe burning sensation occurs, discontinue use immediatelydo not expose the area treated with product to heat or direct sunlight.
Stop use and ask a doctor ifcondition worsensblistering or burning occurspain or swelling occurs
symptoms persist for more than 7 days or clear up and occur again within a fewdays
Do not use if pregnant or breastfeeding.Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center immediately.adults and children 12 years of age and older
apply generously to affected areamassage into painful area until thoroughly absorbed into skinrepeat as necessary, but no more than 3 to 4 times daily
children under 12 years of age: Ask a doctorbeeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil,eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, menthapiperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid,water
Questions or comments? 888-949-4367
For NDC 73096-072 Harmony Hemp Flexible Pain Relief Gel 500Harmony HempFlexible Pain Relief GelMenthol 4%Joint & MuscleCBD Moisturizing Oil500mg per bottleNet Wt 3 oz (85.05 g)Menthol, USP, 4%
Menthol, USP, 4%................................Topical analgesictemporarily relieves minor pain associated with arthritis, simple backache, musclestrains, sprains, bruises, and crampsFor external use onlyWhen using this product
use only as directeddo not bandage tightly or use with a heating padavoid contact with eyes and mucous membranesdo not apply to wounds or damaged, broken, or irritated skina transient burning sensation may occur upon application but generally disappears inseveral daysif severe burning sensation occurs, discontinue use immediatelydo not expose the area treated with product to heat or direct sunlight
Stop use and ask a doctor ifcondition worsensblistering or burning occurspain or swelling occurssymptoms persist for more than 7 days or clear up and occur again within a fewdays
Do not use if pregnant or breastfeeding.Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center immediately.adults and children 12 years of age and older
Apply to affected area no more than 3 to 4 times daily
children under 12 years of age: Ask a doctoraloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract,blue 1, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis leafextract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, industrial hempextract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, silica,tocopheryl acetate, triethanolamine, yellow 5, waterQuestions or comments? 888-949-4367
For NDC 73096-073 Harmony Hemp Flexible Pain Relief Gel 1000Harmony HempFlexible Pain Relief GelMenthol 4%Joint & MuscleCBD Moisturizing Oil1000mg per bottleNet Wt 3 oz (85.05 g)Menthol USP, 4%Menthol USP, 4%...........................Topical analgesictemporarily relieves minor pain associated with arthritis, simple backache, musclestrains, sprains, bruises, and crampsFor external use onlyWhen using this product
use only as directed
do not bandage tightly or use with a heating padavoid contact with eyes and mucous membranesdo not apply to wounds or damaged, broken, or irritated skina transient burning sensation may occur upon application but generally disappears inseveral daysif severe burning sensation occurs, discontinue use immediatelydo not expose the area treated with product to heat or direct sunlight
Stop use and ask a doctor ifcondition worsensblistering or burning occurspain or swelling occurssymptoms persist for more than 7 days or clear up and occur again within a fewdays
Do not use if pregnant or breastfeeding.Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center immediately.adults and children 12 years of age and older
Apply to affected area no more than 3 to 4 times daily
children under 12 years of age: Ask a doctoraloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract,blue 1, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis leafextract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, industrial hempextract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, silica,tocopheryl acetate, triethanolamine, yellow 5, waterQuestions or comments? 888-949-4367
For NDC 73096-074 Harmony Hemp Flexible Pain Relief Roll-on 500Harmony HempFlexiblePain Relief Roll-onMenthol 4%Joint & MuscleCBD Moisturizing Oil500mg per bottleNet Wt 2.5 oz (70.8 g)Menthol USP, 4%Menthol USP, 4%......................Topical analgesictemporary relief of minor aches and pain of muscles and joints associated with simplebackache, arthritis, strains, bruises and sprainsFor external use onlyDo not use
on wounds or damaged skin
When using this productavoid contact with eyes and mucous membranesdo not bandage tightly or use with a heating pad
Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysexcessive skin irritation develops
Do not use if pregnant or breastfeeding.Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center immediately.adults and children 12 years of age and older
Apply to affected area no more than 3 to 4 times dailyWash hands with soap and water after use
children under 12 years of age: Ask a doctorbeeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil,eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, menthapiperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid,waterQuestions or comments? 888-949-4367
For NDC 73096-075 Harmony Hemp Flexible Pain Relief Roll-on 1000Harmony HempFlexiblePain Relief Roll-onMenthol 4%Joint & MuscleCBD Moisturizing Oil1000mg per bottleNet Wt 2.5 oz (70.8 g)Menthol USP, 4%Menthol USP, 4%......................Topical analgesictemporary relief of minor aches and pain of muscles and joints associated with simplebackache, arthritis, strains, bruises and sprainsFor external use onlyDo not use
on wounds or damaged skin
When using this productavoid contact with eyes and mucous membranesdo not bandage tightly or use with a heating pad
Stop use and ask a doctor ifcondition worsenssymptoms persist for more than 7 dayssymptoms clear up and occur again within a few daysexcessive skin irritation develops
Do not use if pregnant or breastfeeding.Keep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center immediately.adults and children 12 years of age and older
Apply to affected area no more than 3 to 4 times dailyWash hands with soap and water after use
children under 12 years of age: Ask a doctorbeeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil,eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, menthapiperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid,waterQuestions or comments? 888-949-4367
HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 500 menthol usp, 4% gel
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:73096-074
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIEDFORM - UNII:L7T10EIP3A)
MENTHOL,UNSPECIFIED FORM
2832 mg in 70.8 g
Inactive IngredientsIngredient Name Strength
YELLOW WAX (UNII: 2ZA36H0S2V) WATER (UNII: 059QF0KO0R) COTTONSEED OIL (UNII: H3E878020N) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) 500 mg in 70.8 gPOLAWAX POLYSORBATE (UNII: Q504PL8E0V) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) CLOVE OIL (UNII: 578389D6D0) TEA TREE OIL (UNII: VIF565UC2G) PEPPERMINT OIL (UNII: AV092KU4JH) SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M) SORBIC ACID (UNII: X045WJ989B)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:73096-
074-02 1 in 1 CARTON 06/26/2019
1 NDC:73096-074-01
70.8 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not aCombination Product
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part348 06/26/2019
HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 500 pain relief gel gel
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:73096-072
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIEDFORM - UNII:L7T10EIP3A)
MENTHOL,UNSPECIFIED FORM
3402 mg in 85.05 g
Inactive IngredientsIngredient Name Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FRANKINCENSE (UNII: R9XLF1R1WM) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAMPHOR, (-)- (UNII: 213N3S8275) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEMP (UNII: TD1MUT01Q7) 500 mg in 85.05 gTROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:73096-
072-02 1 in 1 CARTON 07/10/2019
1 NDC:73096-072-01
85.05 g in 1 BOTTLE, DISPENSING; Type 0: Not aCombination Product
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part348 07/10/2019
HARMONY HEMP FLEXIBLE PAIN RELIEF LOTION500 menthol usp, 4% lotion
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:73096-071
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIEDFORM - UNII:L7T10EIP3A)
MENTHOL,UNSPECIFIED FORM
9068 mg in 226.7 g
Inactive IngredientsIngredient Name Strength
YELLOW WAX (UNII: 2ZA36H0S2V) COTTONSEED OIL (UNII: H3E878020N) POLAWAX POLYSORBATE (UNII: Q504PL8E0V) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) WATER (UNII: 059QF0KO0R) CLOVE OIL (UNII: 578389D6D0)
TEA TREE OIL (UNII: VIF565UC2G) PEPPERMINT OIL (UNII: AV092KU4JH) SHEA BUTTER (UNII: K49155WL9Y) JOJOBA OIL (UNII: 724GKU717M) SORBIC ACID (UNII: X045WJ989B) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) 500 mg in 226.7 g
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:73096-
071-01226.7 g in 1 BOTTLE, PUMP; Type 0: Not aCombination Product 06/26/2019
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part348 06/26/2019
HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 1000 menthol usp, 4% gel
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:73096-075
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIEDFORM - UNII:L7T10EIP3A)
MENTHOL,UNSPECIFIED FORM
2832 mg in 70.8 g
Inactive IngredientsIngredient Name Strength
YELLOW WAX (UNII: 2ZA36H0S2V) WATER (UNII: 059QF0KO0R) COTTONSEED OIL (UNII: H3E878020N) CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S) 1000 mg in 70.8 gPOLAWAX POLYSORBATE (UNII: Q504PL8E0V) EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6) CLOVE OIL (UNII: 578389D6D0) TEA TREE OIL (UNII: VIF565UC2G) PEPPERMINT OIL (UNII: AV092KU4JH) SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL (UNII: 724GKU717M) SORBIC ACID (UNII: X045WJ989B)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:73096-
075-02 1 in 1 CARTON 06/26/2019
1 NDC:73096-075-01
70.8 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not aCombination Product
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part348 06/26/2019
HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 1000 menthol usp, 4% gel
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:73096-073
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIEDFORM - UNII:L7T10EIP3A)
MENTHOL,UNSPECIFIED FORM
3402 mg in 85.05 g
Inactive IngredientsIngredient Name Strength
FD&C YELLOW NO. 5 (UNII: I753WB2F1M) ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FRANKINCENSE (UNII: R9XLF1R1WM) CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAMPHOR, (-)- (UNII: 213N3S8275) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) GLYCERIN (UNII: PDC6A3C0OX) ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
Abacus Health Products, Inc.
ISOPROPYL ALCOHOL (UNII: ND2M416302) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEMP (UNII: TD1MUT01Q7) 1000 mg in 85.05 gTROLAMINE (UNII: 9O3K93S3TK) ALOE VERA LEAF (UNII: ZY81Z83H0X)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:73096-
073-02 1 in 1 CARTON 07/10/2019
1 NDC:73096-073-01
85.05 g in 1 BOTTLE, DISPENSING; Type 0: Not aCombination Product
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part348 07/10/2019
Labeler - Abacus Health Products, Inc. (116931574)
EstablishmentName Address ID/FEI Business Operations
Aidance Scientific, Inc, DBA Aidance Skincare & TopicalSolutions 018950611 manufacture(73096-071, 73096-074,
73096-075)
EstablishmentName Address ID/FEI Business Operations
Inspec Solutions 081030372 manufacture(73096-072, 73096-073)
Revised: 2/2021
