Flexible Pain Relief Line

Harmony Hemp Flexible Pain Relief Gel 1000 by

Drug Labeling and Warnings

Harmony Hemp Flexible Pain Relief Gel 1000 by is a Otc medication manufactured, distributed, or labeled by Abacus Health Products, Inc., Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions, Inspec Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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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
• symptoms persist for more than 7 days or clear up and occur again within a few days

Do not use if pregnant or breastfeeding.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

adults and children 12 years of age and older

• apply generously to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary, but no more than 3 to 4 times daily

children under 12 years of age: Ask a doctor

beeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil, eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita (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 500

Harmony Hemp

Flexible Pain Relief Gel

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

500mg per bottle

Net Wt 3 oz (85.05 g)

Menthol, USP, 4%

Menthol, USP, 4%................................Topical analgesic

temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps

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
• symptoms persist for more than 7 days or clear up and occur again within a few days

Do not use if pregnant or breastfeeding.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control 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 doctor

aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, blue 1, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, industrial hemp extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, silica, tocopheryl acetate, triethanolamine, yellow 5, water

Questions or comments?888-949-4367

For NDC: 73096-073 Harmony Hemp Flexible Pain Relief Gel 1000

Harmony Hemp

Flexible Pain Relief Gel

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

1000mg per bottle

Net Wt 3 oz (85.05 g)

Menthol USP, 4%

Menthol USP, 4%...........................Topical analgesic

temporarily relieves minor pain associated with arthritis, simple backache, muscle strains, sprains, bruises, and cramps

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
• symptoms persist for more than 7 days or clear up and occur again within a few days

Do not use if pregnant or breastfeeding.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control 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 doctor

aloe barbadensis leaf extract, arctium lappa root extract, arnica montana flower extract, blue 1, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis leaf extract, camphor, carbomer, glycerin, ilex paraguariensis leaf extract, industrial hemp extract, isopropyl alcohol, isopropyl myristate, melissa officinalis leaf extract, silica, tocopheryl acetate, triethanolamine, yellow 5, water

Questions or comments?888-949-4367

For NDC: 73096-074 Harmony Hemp Flexible Pain Relief Roll-on 500

Harmony Hemp

Flexible

Pain Relief Roll-on

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

500mg per bottle

Net Wt 2.5 oz (70.8 g)

Menthol USP, 4%

Menthol USP, 4%......................Topical analgesic

temporary relief of minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

For external use only

Do not use

• on wounds or damaged skin

When using this product

• avoid contact with eyes and mucous membranes
• do not bandage tightly or use with a heating pad

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation develops

Do not use if pregnant or breastfeeding.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

adults and children 12 years of age and older

• Apply to affected area no more than 3 to 4 times daily
• Wash hands with soap and water after use

children under 12 years of age: Ask a doctor

beeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil, eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid, water

Questions or comments?888-949-4367

For NDC: 73096-075 Harmony Hemp Flexible Pain Relief Roll-on 1000

Harmony Hemp

Flexible

Pain Relief Roll-on

Menthol 4%

Joint & Muscle

CBD Moisturizing Oil

1000mg per bottle

Net Wt 2.5 oz (70.8 g)

Menthol USP, 4%

Menthol USP, 4%......................Topical analgesic

temporary relief of minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

​For external use only

Do not use

• on wounds or damaged skin

When using this product

• avoid contact with eyes and mucous membranes
• do not bandage tightly or use with a heating pad

Stop use and ask a doctor if

• condition worsens
• symptoms persist for more than 7 days
• symptoms clear up and occur again within a few days
• excessive skin irritation develops

​Do not use if pregnant or breastfeeding.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

adults and children 12 years of age and older

• Apply to affected area no more than 3 to 4 times daily
• Wash hands with soap and water after use

children under 12 years of age: Ask a doctor

beeswax, CBD hemp oil, cottonseed oil, emulsifying wax, eucalyptus globulus leaf oil, eugenia caryophyllus (clove) flower oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita (peppermint) oil, shea butter, simmondsia chinensis (jojoba) seed oil, sorbic acid, water

Questions or comments?888-949-4367

HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 500 
menthol usp, 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-074
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2832 mg  in 70.8 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
WATER (UNII: 059QF0KO0R)
COTTONSEED OIL (UNII: H3E878020N)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)	500 mg  in 70.8 g
POLAWAX 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 Date	Marketing End Date
1	NDC: 73096-074-02	1 in 1 CARTON	06/26/2019	12/22/2023
1	NDC: 73096-074-01	70.8 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/26/2019	12/22/2023

HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 500 
pain relief gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	3402 mg  in 85.05 g

Inactive Ingredients
Ingredient 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 g
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-072-02	1 in 1 CARTON	07/10/2019	12/22/2023
1	NDC: 73096-072-01	85.05 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/10/2019	12/22/2023

HARMONY HEMP FLEXIBLE PAIN RELIEF LOTION500 
menthol usp, 4% lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	9068 mg  in 226.7 g

Inactive Ingredients
Ingredient 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 Date	Marketing End Date
1	NDC: 73096-071-01	226.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/26/2019	12/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/26/2019	12/22/2023

HARMONY HEMP FLEXIBLE PAIN RELIEF ROLL-ON 1000 
menthol usp, 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	2832 mg  in 70.8 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
WATER (UNII: 059QF0KO0R)
COTTONSEED OIL (UNII: H3E878020N)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)	1000 mg  in 70.8 g
POLAWAX 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 Date	Marketing End Date
1	NDC: 73096-075-02	1 in 1 CARTON	06/26/2019	12/22/2023
1	NDC: 73096-075-01	70.8 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/26/2019	12/22/2023

HARMONY HEMP FLEXIBLE PAIN RELIEF GEL 1000 
menthol usp, 4% gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-073
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	3402 mg  in 85.05 g

Inactive Ingredients
Ingredient 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)	1000 mg  in 85.05 g
TROLAMINE (UNII: 9O3K93S3TK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-073-02	1 in 1 CARTON	07/10/2019	12/22/2023
1	NDC: 73096-073-01	85.05 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/10/2019	12/22/2023

Labeler - Abacus Health Products, Inc. (116931574)

Establishment
Name	Address	ID/FEI	Business Operations
Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions		018950611	manufacture(73096-071, 73096-074, 73096-075)

Establishment
Name	Address	ID/FEI	Business Operations
Inspec Solutions		081030372	manufacture(73096-072, 73096-073)

Revised: 12/2023

Document Id: 0d9a151b-186f-66b2-e063-6294a90ad296

34390-5

Set id: bc09bfaf-d220-60c6-e053-2a95a90a5dc9

Version: 5

Effective Time: 20231228