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
  • 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 January 20, 2022

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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 finalpart333C05/04/2011
    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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