Label: MENTHOLATUM HEEL REVIVAL CREAM cream

  • NDC Code(s): 10742-0020-1
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 9, 2024

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  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Tolnaftate - Antifungal

  • Uses

    • proven clinically effective in the treatment of most cracked heel athlete’s foot
    • relieves cracking, irritation and discomfort
    • prevents the recurrence of most cracked heel athlete's foot with daily use
    • Clears up most athlete’s foot infection and with daily use helps keep it from coming back
  • Warnings

    For external use only

    Do not use

    on children under 2 years of age unless directed by a doctor.

    When using this product,

    avoid contact with the eyes.

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks
  • Directions

    • clean the affected area and dry thoroughly
    • apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
    • supervise children in the use of this product
    • for athlete’s foot: pay special attention to the areas between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
    • for athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor
    • this product is not effective on the scalp or nails
  • Inactive ingredients

    water, caprylic/capric triglyceride, urea, cetyl alcohol, glycerin, glycine, hexadecane, tridecyl stearate, ethoxydiglycol, ceteth-23, polyacrylate crosspolymer-6, diethyl sebacate, dimethicone, hydroxyethylcellulose, lactic acid, phenoxyethanol, propylene glycol caprylate, simmondsia chinensis (jojoba) seed oil, sodium dilauramidoglutamide lysine, sorbitan stearate, squalane, zinc oxide

  • Questions?

    1-877-636-2677 MON-FRI 9AM-5PM (EST)

  • Keep Out of Reach of Children

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

  • Drug Facts

    FrontPrinicipal Display Panel

  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM HEEL REVIVAL CREAM 
    mentholatum heel revival cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-0020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHOXYDIGLYCOL (UNII: A1A1I8X02B)  
    DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T)  
    CETETH-23 (UNII: 495CTZ441V)  
    SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    DIETHYL SEBACATE (UNII: I41B9FJK6V)  
    SORBITAN STEARATE (UNII: NVZ4I0H58X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXADECANE (UNII: F8Z00SHP6Q)  
    POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    UREA (UNII: 8W8T17847W)  
    HYDROXYETHYLCELLULOSE (UNII: T4V6TWG28D)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCINE (UNII: TE7660XO1C)  
    SODIUM DILAURAMIDOGLUTAMIDE LYSINE (UNII: MNJ7VPT2R5)  
    TRIDECYL STEARATE (UNII: A8OE252M6L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-0020-11 in 1 CARTON09/30/2024
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/12/2024
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-0020)