Label: WALGREENS TOLNAFTATE- tolnaftate cream

  • NDC Code(s): 0363-1298-00, 0363-1298-01
  • Packager: WALGREEN COMPANY
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 10, 2024

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  • SPL UNCLASSIFIED SECTION

    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)
    • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.
  • Inactive ingredients

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

  • Questions or comments?

    1-866-323-0107

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    WALGREEN CO.
    200 WILMOT RD.,
    DEERFIELD, IL 60015

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    NDC 0363-1298-00

    Walgreens
    Compare to the active ingredient in
    Tough Actin' Tinactin® Antifungal Cream††

    • WALGREENS •
    PHARMACIST RECOMMENDED†

    Athlete's
    Foot
    Cream
    TOLNAFTATE 1% / ANTIFUNGAL

    Medicated
    Antifungal

    • Cures & prevents
      most athlete's foot
    • Relieves itching & burning

    1
    TUBE

    NET WT 1 OZ (28 g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    WALGREENS TOLNAFTATE 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1298
    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
    MINERAL OIL (UNII: T5L8T28FGP)  
    CETETH-20 (UNII: I835H2IHHX)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    WATER (UNII: 059QF0KO0R)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1298-001 in 1 CARTON05/04/201101/08/2019
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0363-1298-011 in 1 CARTON12/10/2018
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00505/04/2011
    Labeler - WALGREEN COMPANY (008965063)
    Registrant - UNITED EXCHANGE CORP. (840130579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taiguk Pharm. Co., Ltd._Buyeo branch689060246manufacture(0363-1298)
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