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

If you are a consumer or patient please visit this version.

  • 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

    Label

    LABEL

  • INGREDIENTS AND APPEARANCE
    FLEXIGEN 
    menthol 1.25% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72839-371
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.25 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72839-371-0395 mL in 1 BOTTLE; Type 0: Not a Combination Product07/11/2022
    2NDC:72839-371-015 mL in 1 BOTTLE; Type 0: Not a Combination Product07/11/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/11/2022
    Labeler - Derma Care Research Labs, LLC (116817470)
    Registrant - Derma Care Research Labs, LLC (116817470)