Label: SKINHEAL ANTIFUNGAL- tolnaftate cream

  • NDC Code(s): 69070-305-01
  • Packager: Zhejiang Dingtai Pharmaceutical 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 May 21, 2019

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient
    Tolnaftate 1.0%

  • PURPOSE

    Purpose
    Antifungal

  • INDICATIONS & USAGE

    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 unless directed by 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

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children 2 years of age or older:

       wash the affected area and dry thoroughly

       apply a thin layer of the product over the 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

          change shoes and socks at least once daily
       use daily for 4 weeks for the treatment of athlete’s foot and ringworm
          if condition persists longer, consult a doctor
          use daily for the prevention of athlete’s foot

       this product is not effective on the scalp or nails
    Children under 2 years: do not use unless directed by a doctor

  • STORAGE AND HANDLING

    Other information
    keep container tightly closed

    store between 15 and 30 C (59 to 86 F)

  • INACTIVE INGREDIENT

    Inactive ingredients  cetostearyl alcohol, glycerin, glyceryl monostearate, petrolatum, propylene glycol, sodium sulfite, steareth- 20, stearic acid, and water

  • QUESTIONS

    Questions or comments? (888) 221-3496 M-F 9am-5pm
    you may also report serious side effects to this phone number

  • PRINCIPAL DISPLAY PANEL

    SKINHEAL ANTIFUNGAL CREAM
    Tolnaftate 1%
    Net Wt. 10 g (1/3 oz)
    NDC 69070-305-01
    Box2.jpg

  • INGREDIENTS AND APPEARANCE
    SKINHEAL ANTIFUNGAL 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69070-305
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69070-305-011 in 1 BOX12/10/2018
    110 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/10/2018
    Labeler - Zhejiang Dingtai Pharmaceutical Co., Ltd (420598724)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(69070-305)