FLEXIGEN- menthol 1.25% cream

Flexigen by

Drug Labeling and Warnings

Flexigen by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 1.25%

PURPOSE

Pain Relieving Cream

INDICATIONS & USAGE

For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.

WARNINGS

For external use only. Do not use with other topical pain relievers, with heating pads or heating devices. When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Extract, Boswellia Carterii Oil, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Citrus Sinensis (Orange) Peel Oil, Cocos Nucifera (Coconut) Oil, Dimethicone, Disodium EDTA, Ethylhexylglyerin, Glycerin, Glyceryl Stearate SE, Hydrolyzed Rice Protein, Lavandula Angustifolia (Lavender) Oil, Phenoxyethanol, Polysorbate 60, Sesamum Indicum (Sesame) Seed Oil, Stearyl Alcohol, Tocopherol, Water, Xanthan Gum.

PREGNANCY

If pregnant or breast-feeding, ask a health professional before use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FLEXIGEN 
menthol 1.25% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-371
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
FRANKINCENSE OIL (UNII: 67ZYA5T02K)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
LAVENDER OIL (UNII: ZBP1YXW0H8)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
RICE BRAN (UNII: R60QEP13IC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CHAMOMILE (UNII: FGL3685T2X)
TOCOPHEROL (UNII: R0ZB2556P8)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SESAME OIL (UNII: QX10HYY4QV)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ORANGE PEEL (UNII: TI9T76XD44)
COCONUT OIL (UNII: Q9L0O73W7L)
DIMETHICONE 200 (UNII: RGS4T2AS00)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-371-03	95 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2022
2	NDC: 72839-371-01	5 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/11/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/11/2022

Labeler - Derma Care Research Labs, LLC (116817470)

Registrant - Derma Care Research Labs, LLC (116817470)