Label: ATOPALM TOLNAFTATE ANTIFUNGAL- tolnaftate cream

  • 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 June 5, 2015

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

  • Active Ingredients

    Tolnaftate 1%


  • Purpose


    Antifungal

  • Uses

    cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)

    helps prevent most athletes foot from recurring when used daily

    effectively relieves itching, burning and cracking.

  • Warnings

    For external use only

    When using this product

    avoid contact with the eyes

    Stop use and ask a doctor if

    irritation occurs
    if there is no improvement within 4 weeks

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age except under the advice and supervision of a doctor.

  • Directions

    wash affected area and pat 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 a day.

    use daily for 4 weeks, if condition persists longer, ask a doctor

    to prevent athlete's foot, apply once or twice daily (morning and/or night)

    this product not effective on the scalp or nails.

  • Other Information

    store between 20 to 30 C (68 to 86)F

    see end of carton or tube crimp for lot number and expiration date.

  • Inactive Ingredients

    Water, glycerin, Cetyl alcohol, mineral oil, PEG-15 Glyeryl Stearate, Glyceryl Stearate, Stearic Acid, Carbomer 94-, Cholesterol, Disodium Phosphate, Myristoyl/Palmitoyl Oxostearamide/Archamide MEA, p-Chloro-m-cresol

  • Questions?

    Call 1-855-ATOPALM

  • PRINCIPAL DISPLAY PANEL

    Relieves itching, burning, cracking of athlete's foot

    Effective relief of symptoms of ringworm
    Tolnaftate 1%

    ATOPALM
    Antifungal Cream

    with US Patented MLE Technology

    Effective Infection Protection for cuts, scrapes and burns


    ATOPALM
    1% Tolnaftate Antifungal Cream

    Cures All Major Types of Athletes Foot Fungus

    Net wt. 1oz/28.3g


    Distributed by: NeoPharm Co., Ltd 80 Wood Rd, 212 Camarillo, CA 93010

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    ATOPALM First Aid Antibiotic

  • PRINCIPAL DISPLAY PANEL

    ATOPALM First Aid Antibiotic

  • INGREDIENTS AND APPEARANCE
    ATOPALM TOLNAFTATE ANTIFUNGAL  
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-2000
    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
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-15 GLYCERYL STEARATE (UNII: 91245SPD5K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    PHOSPHATE ION (UNII: NK08V8K8HR)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-2000-11 in 1 CARTON
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/16/2011
    Labeler - Neopharm Co., Ltd. (965502912)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd.631101883manufacture(51141-2000)