Label: SIGNATURE CARE ANTIFUNGAL CREAM TOLNAFTATE 1%- tolnaftate cream

  • NDC Code(s): 21130-887-14
  • Packager: BETTER LIVING BRANDS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 30, 2022

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

  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Tolnaftate 1%.............................................................Antifungal

  • PURPOSE

    Uses

    • proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • helps prevent most athlete's foot with daily use
    • for effective relief of itching, burning and cracking
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use on children under 2 years of age, except under the advice and supervision of a doctor.

  • WHEN USING

    When using this product, avoid contact with the eyes

  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks
  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • wash 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 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. If conditions persists longer, consult a doctor.
    • to prevent athlete's foot, apply once or twice daily (morning and/or night)
    • this product is not effective on the scalp or nails
  • INACTIVE INGREDIENT

    Inactive ingredients cetostearyl alcohol, ethylparaben, glycerin, glyceryl, monostearate, petrolatum, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

  • DOSAGE & ADMINISTRATION

    Distributed by Better Living Brands LLC

    P.O. Box 99, Pleasanton, CA 94566

    1-888-723-3929

    Made in China

  • PRINCIPAL DISPLAY PANEL

    78805.1

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE ANTIFUNGAL CREAM TOLNAFTATE 1% 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-887
    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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-887-141 in 1 CARTON09/25/2022
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/04/2022
    Labeler - BETTER LIVING BRANDS LLC (009137209)