Label: DERMAN ANTIFUNGAL CREAM- tolnaftate cream

  • NDC Code(s): 81929-004-01, 81929-004-02
  • Packager: Taisho Pharmaceutical California Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Drug Facts

  • Active ingredient

    Tolnaftate 1%

    Purpose

    Antifungal

  • Uses

    • cures most athlete's foot, jock itch, and ringworm 
    • relieves itching, burning, cracking, scaling, redness, soreness, irritation and discomfort
  • Warnings

    Do not use

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

    For external use only.

    Avoid contact with eyes.

    Stop use and ask a doctor if 

    • irritation occurs
    • there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • wash affected area and dry thoroughly
    • apply a thin layer 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 spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
    • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks 
    • if condition persists longer, consult a doctor 
    • this product is not effective on the scalp or nails
  • Other information

    store at 15 to 30°C (59° to 86°F)

    DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING. Tamper Evident:

  • Inactive ingredients

    ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

  • Package Labeling:25g

    box

    tube

  • Package Labeling:50g

    box50

    tube50

  • INGREDIENTS AND APPEARANCE
    DERMAN ANTIFUNGAL CREAM 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81929-004
    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
    CETETH-20 (UNII: I835H2IHHX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81929-004-021 in 1 CARTON07/01/2022
    125 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:81929-004-011 in 1 CARTON07/01/2022
    250 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00507/01/2022
    Labeler - Taisho Pharmaceutical California Inc. (603827635)
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