Label: AVON HEXASHIELD ATHLETES FOOT CREAM- tolnaftate cream

  • NDC Code(s): 43136-104-01
  • Packager: Tai Guk Pharm. Co., Ltd.
  • 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 July 31, 2019

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  • Active Ingredient

    Tolnaftate 1 %

  • Purpose

    Antifulgal

  • 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

    For external use only.

    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

    Do not use on children

    • under 2 years of age except under the advice and supervision of a doctor

    Keep out of reach of children.

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

  • Directions

    • wash affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night)
    • 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
    • use daily for 4 weeks; if condition persists longer, ask a doctor
    • to prevent athlete's foot, apply once or twice daily (morning and night)
    • this product is not effective on the scalp or nails
  • Other information

    • store at room temperature
    • Lot No. & Exp. Date: see box or crimp of tube
  • Inactive Ingredients

    butylated hydroxytolune, ceteth-20, cetyl alcohol, methylparaben, mineral oil, propylparaben, sorbitan monostearate, stearyl alcohol, water

  • Questions or comments?

    Call toll free 1-800-FOR-AVON

    www.avon.com

  • Principal Display Panel

    HeXasheild

    Compare to the active ingredient in Tinactin®

    Cures & Prevents Most Athlete's Foot

    AVON

    EFFECTIVE TREATMENT OF:

    - ATHLETE'S FOOT - JOCK ITCH - RINGWORM

    HeXashield

    ATHLETE'S FOOT CREAM

    TOLNAFTATE 1% ANTIFUNGAL CREAM

    NET WT 1 oz (28 g)

    AVON ATHLETES FOOT CREAM_1

    AVON ATHLETES FOOT CREAM_DF

  • INGREDIENTS AND APPEARANCE
    AVON HEXASHIELD ATHLETES FOOT  CREAM
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43136-104
    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
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    CETETH-20 (UNII: I835H2IHHX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43136-104-011 in 1 CARTON07/31/2019
    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 finalpart333C07/31/2019
    Labeler - Tai Guk Pharm. Co., Ltd. (689060246)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tai Guk Pharma. Co., Ltd.689060246manufacture(43136-104)
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