Label: ATHLETES FOOT ANTIFUNGAL ANTIFUNGAL- clotrimazole cream

  • Category: HUMAN OTC DRUG LABEL

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 July 25, 2020

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  • Active ingredients

    Drug Facts

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Keep out of reach of children

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

  • Uses

    • cures most athlete's foot
    • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  • Warnings

    For external use only

    Do not use on children under 2 years of age unless directed by a doctor

    When using this product avoid contact with the eyes

    Stop use and consult a doctor if

    • irritation occurs
    • there is no improvement within 2 weeks
  • Directions

    This product is not effective on the scalp or nails

    • clean the affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night) or as directed by a doctor. Pay special attention between the toes. Wear well fitting, ventilated shoes and change shoes and socks at least once a day.
    • supervise children in the use of this product
    • use daily for 4 weeks
    • if condition persists longer, ask a doctor
  • Other information

    • store at temperature between 59° - 86° F  (15° - 30° C)
    • do not use if seal on tube is punctured or missing
  • Inactive ingredients

    bees wax, cetryl alcohol, disodium EDTA, glyceryl stearate, methyl paraben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propyl paraben, purified water, sorbitan tristerate, Sodium Hydroxide.

  • Product Label

    DRUGSTORE-Rx

    SMART WELLNESS

    Clotrimazole USP 1%

    Athlete's Foot

    Antifungal Cream

    Cures most major types of athlete's foot

    Relieves

    •  Itching
    • Burning
    • Scaling
    • Cracking

    Greaseless

    Odorless

    Non-staining

    NET WT. 1.25 OZ.  (35 g)

    DRUGSTORE-Rx

    SMART WELLNESS delivers outstanding quality in healthcare products, at truly amazing prices. We employ the highest standard when searching the world to bring the best value to your doorstep. Use our products confidently, knowing that attention and care has gone into every item. That's smart wellness!

    Distributed by: PERSONAL CARE PRODUCTS, LLC
    Troy, Michigan 48084 U.S.A.

    Code No. MH/DRUGS/KD-313               Made in India


    PC AthletesFoot1 Label

    PC AthletesFoot2 Label

  • INGREDIENTS AND APPEARANCE
    ATHLETES FOOT ANTIFUNGAL  ANTIFUNGAL
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29500-2435
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE350 mg  in 35 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN TRISTEARATE (UNII: 6LUM696811)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29500-2435-135 g in 1 TUBE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/10/2013
    Labeler - Personal Care Products, Inc. (966155082)
    Registrant - Personal Care Products, Inc. (966155082)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd.916837425manufacture(29500-2435)
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