Label: FLEXIGEN- menthol 1.25% cream
- NDC Code(s): 72839-371-01, 72839-371-03
- Packager: Derma Care Research Labs, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 15, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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
- DOSAGE & ADMINISTRATION
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLEXIGEN
menthol 1.25% creamProduct 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)