QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]

QUALITY CHOICE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC 63868-104-46
Set ID 684e9447-e16e-42e2-b268-e37b48eb2e92
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association Inc
Generic Name
Product Class
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Active ingredient                                                                  Purpose

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

  • PURPOSE

    Uses

    • clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
    • helps prevent most athlete's foot recurring when used daily
    • effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet
  • WARNINGS

    Warnings For external use only

  • 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
  • DO NOT USE

    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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 space between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least one daily
    • use daily for 4 weeks; if condition persists longer, ask a doctor
    • 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
  • STORAGE AND HANDLING

    Other information

    • store between 2° and 30° C (36° and 86° F)
    • Lot No. and Exp. Date:see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients propylene glycol, liquid paraffin, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben

  • DOSAGE & ADMINISTRATION

    Distributed By Quality Choice

    Novi, Mi 48376-0995

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE TOLNAFTATE ANTIFUNGAL 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    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:63868-104-461 in 1 CARTON05/31/2013
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/31/2013
    Labeler - Chain Drug Marketing Association Inc (011920774)