Label: ATOPALM CLOTRIMAZOLE ANTIFUNGAL- clotrimazole 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 May 28, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Clotrimazole 1%

  • PURPOSE

    Purpose

    Antifungal

  • INDICATIONS & USAGE

    Uses

    • cures most athlete's foot, jock itch and ringworm
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.
  • WARNINGS

    Warnings       For external use only.

    Do not use on diaper rash or on children under 2 years of age unless directed by a doctor.


    When using this product avoid contact with the eyes

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot and ring worm) or 2 weeks (for jock itch).
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    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 toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day.
    • for athlete's foot and ringworm, use daily for 4 weeks, for jock itch use daily for 2 weeks
    • if condition persists longer, ask a doctor
    • this product not effective on the scalp or nails
  • STORAGE AND HANDLING

    Other Information

    • store at 20 degrees to 25 degrees  (68 degrees to 77 degrees F)
    • see end of carton or tube crimp for lot number and expiration date
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Glycerin,Cetyl Alcohol, Mineral Oil, Glyceryl Stearate, PEG Glyceryl Stearate, Stearic Acid, Benzyl Alcohol, Carbomer 940, Cholesterol, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Triethanolamine

  • QUESTIONS

    Questions? Call 1-855-ATOPALM

  • SPL UNCLASSIFIED SECTION

    US Patent US 6221371B1

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

    Made in Korea

  • SPL UNCLASSIFIED SECTION

    Clotrimazole 1%
    Antifungal
    Cream
  • Product Labeling

    image description
    image description

  • INGREDIENTS AND APPEARANCE
    ATOPALM CLOTRIMAZOLE ANTIFUNGAL  
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-1000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-1000-11 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(51141-1000)
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