FLEXIBLE PAIN RELIEF GEL EXTRA STRENGTH- pain relief gel extra strength gel FLEXIBLE PAIN RELIEF ROLL-ON EXTRA STRENGTH- pain relief roll-on extra strength gel FLEXIBLE PAIN RELIEF ROLL-ON- pain relief roll-on gel FLEXIBLE PAIN RELIEF GEL- pain relief gel gel FLEXIBLE PAIN RELIEF- pain relief lotion lotion

Flexible Pain Relief by

Drug Labeling and Warnings

Flexible Pain Relief by is a Homeopathic medication manufactured, distributed, or labeled by ABACUS HEALTH PRODUCTS, INC., Inspec Solutions LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

For NDC:

73096-026-01 Flexible Pain Relief

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum

Active ingredient Menthol 2%

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

Purpose Menthol 2%....................................................Topical Analgesic

Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains

Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water

Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days

Warnings: For external use only

For NDC:

73096-027-01 Flexible Pain Relief Gel

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum

Active ingredient Menthol 2%

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

Purpose Menthol 2%....................................................Topical Analgesic

Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains

Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water

Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days

Warnings: For external use only

For NDC:

73096-028-01 Flexible Pain Relief Extra Strength Gel

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum

Active ingredient Menthol 2.5%

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

Purpose Menthol 2.5%....................................................Topical Analgesic

Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains

Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water

Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days

Warnings: For external use only

For NDC:

73096-029-01 Flexible Pain Relief Roll-on

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum

Active ingredient Menthol 2%

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

Purpose Menthol 2%....................................................Topical Analgesic

Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains

Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water

Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days

Warnings: For external use only

For NDC:

73096-030-01 Flexible Pain Relief Extra Strength Roll-on

Aloe barbadensis Leaf (Aloe Vera) Juice, Arnica Montana Flower Extract, Deionized Water, Dimethyl Sulfone, Ethylhexylglycerin, Eucalyptus globulus Leaf Oil, Glucosamine Sulfate - Glucosamine Sulfate Potassium Chloride, Glycerin, Hemp Extract, Hempseed Oil, Phenoxyethanol, Polysorbate 20, Salix alba, Phenoxyethanol, Polysorbate 20, Salix alba (Willow) bark extract, Symphytum Officinale (Comfrey) Leaf Extract, Xanthan Gum

Active ingredient Menthol 2.5%

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

Purpose Menthol 2.5%....................................................Topical Analgesic

Uses: For the temporary relief of minor aches and pains -arthritis -simple backache -strains -bruises -sprains

Directions for adults and children 12 years of age and over: -shake well -apply to affected area not more than 4 times daily -massage painful area until absorbed into skin -wash hands after each use with cold water

Stop use and ask a doctor if -condition worsens -rash, itching, redness or excessive irritation of the skin develops -symptoms last more than 7 days -symptoms clear up and occur again within a few days

Warnings: For external use only

INGREDIENTS AND APPEARANCE

FLEXIBLE PAIN RELIEF GEL EXTRA STRENGTH 
pain relief gel extra strength gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-028
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	2410 mg  in 96.4 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
COMFREY LEAF (UNII: DG4F8T839X)
SAFFLOWER OIL (UNII: 65UEH262IS)
WATER (UNII: 059QF0KO0R)
OLIVE OIL (UNII: 6UYK2W1W1E)
EDETATE SODIUM (UNII: MP1J8420LU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
GLYCERIN (UNII: PDC6A3C0OX)
HEMP (UNII: TD1MUT01Q7)	1000 mg  in 96.4 g
SALIX ALBA BARK (UNII: 205MXS71H7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-028-02	1 in 1 CARTON	07/10/2019
1	NDC: 73096-028-01	96.4 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 not final	part348	07/10/2019

FLEXIBLE PAIN RELIEF ROLL-ON EXTRA STRENGTH 
pain relief roll-on extra strength gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-030
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	2126 mg  in 85.05 g

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
COMFREY LEAF (UNII: DG4F8T839X)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
GLYCERIN (UNII: PDC6A3C0OX)
HEMP (UNII: TD1MUT01Q7)	1000 mg  in 85.05 g
SALIX ALBA BARK (UNII: 205MXS71H7)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-030-02	1 in 1 CARTON	07/10/2019
1	NDC: 73096-030-01	85.05 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 not final	part348	07/10/2019

FLEXIBLE PAIN RELIEF ROLL-ON 
pain relief roll-on gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-029
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	1701 mg  in 85.05 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
COMFREY LEAF (UNII: DG4F8T839X)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
GLYCERIN (UNII: PDC6A3C0OX)
HEMP (UNII: TD1MUT01Q7)	500 mg  in 85.05 g
SALIX ALBA BARK (UNII: 205MXS71H7)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-029-02	1 in 1 CARTON	06/26/2019
1	NDC: 73096-029-01	85.05 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 not final	part348	06/26/2019

FLEXIBLE PAIN RELIEF GEL 
pain relief gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-027
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	1928 mg  in 96.4 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
COMFREY LEAF (UNII: DG4F8T839X)
SAFFLOWER OIL (UNII: 65UEH262IS)
WATER (UNII: 059QF0KO0R)
OLIVE OIL (UNII: 6UYK2W1W1E)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
EDETATE SODIUM (UNII: MP1J8420LU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
GLYCERIN (UNII: PDC6A3C0OX)
HEMP (UNII: TD1MUT01Q7)	500 mg  in 96.4 g
SALIX ALBA BARK (UNII: 205MXS71H7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-027-02	1 in 1 CARTON	07/10/2019
1	NDC: 73096-027-01	96.4 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 not final	part348	07/10/2019

FLEXIBLE PAIN RELIEF 
pain relief lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73096-026
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	4534 mg  in 226.7 g

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 20 (UNII: 7T1F30V5YH)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
COMFREY LEAF (UNII: DG4F8T839X)
SAFFLOWER OIL (UNII: 65UEH262IS)
WATER (UNII: 059QF0KO0R)
OLIVE OIL (UNII: 6UYK2W1W1E)
EDETATE SODIUM (UNII: MP1J8420LU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)
GLYCERIN (UNII: PDC6A3C0OX)
HEMP (UNII: TD1MUT01Q7)	500 mg  in 226.7 g
SALIX ALBA BARK (UNII: 205MXS71H7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73096-026-01	226.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/26/2019

Labeler - Harmony Product LLC (117041828)

Registrant - Steuart Custom Manufacturing (116952121)

Establishment
Name	Address	ID/FEI	Business Operations
Steuart Custom Manufacturing		116952121	manufacture(73096-026, 73096-027, 73096-028, 73096-029, 73096-030)