WALGREENS TOLNAFTATE (TOLNAFTATE) CREAM [WALGREEN COMPANY]

WALGREENS TOLNAFTATE (TOLNAFTATE) CREAM [WALGREEN COMPANY]
PDF | XML

NDC 0363-1298-00, 0363-1298-01
Set ID c9e3cc96-43b1-411e-a394-45598e7b4731
Category HUMAN OTC DRUG LABEL
Packager WALGREEN COMPANY
Generic Name
Product Class
Product Number
Application Number PART333C
  • 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
  • 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 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
    • to prevent athlete's foot, apply once or twice daily (morning and/or night)
    • This product is not effective on the scalp or nails
  • STORAGE AND HANDLING

    Other Information

    • Store between 20-25oC (68-77oF)
  • INACTIVE INGREDIENT

    Inactive Ingredients

    butylated hydroxytoluene, cetanol, ceteth-20, liquid paraffin, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

  • QUESTIONS

    Questions or comments?

    Call 1-800-814-8028

  • DOSAGE & ADMINISTRATION

    Distributed by: Walgreen Co.

    200 Wilmot Rd., Deerfield, IL 60015-4616

    Made in Korea

  • 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)

Related Drugs