CLOTRIMAZOLE CREAM [LIFELABS, A DIVISION OF ATICO INTERNATIONAL USA, INC.]

CLOTRIMAZOLE CREAM [LIFELABS, A DIVISION OF ATICO INTERNATIONAL USA, INC.]
PDF | XML

NDC 51852-103-01
Set ID bca482ac-4b65-450e-bc27-c50af9cd0416
Category HUMAN OTC DRUG LABEL
Packager LIFElabs, a Division of Atico International USA, INC.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Clotrimazole

    Active Ingredient

    Clotrimazole 1%

  • PURPOSE

    Purpose

    Antifungal

    Uses

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

    Warnings

    Do not use on children under 2 years of age except under the advice and supervision of a doctor.

    For external use only.

  • INDICATIONS & USAGE

    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 (for athlete's foot and ringworm) or 2 weeks (for jock itch)
    • do not use for diaper rash
  • 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

    • 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 the 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 conditions persist longer, ask a doctor
    • this product is not effective on the scalp or nails
  • STORAGE AND HANDLING

    Other information

    store between 2o and 30o C (30o and 86o F) Lot No. and Exp. Date: see box or see crimp of tube

  • INACTIVE INGREDIENT

    Inactive ingredients

    benzyl alcohol, isopropyl myristate, liquid parafin, polysorbate 60, propylene glycol, purified water, stearic acid, stearyl aclohol, sorbitan monostearate

  • QUESTIONS

    Questions?

    Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

  • PRINCIPAL DISPLAY PANEL

    mage of Clotrimazole Antifungal Cream Carton Label

    mage of Clotrimazole Antifungal Cream Tube Label



  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51852-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Benzyl Alcohol (UNII: LKG8494WBH)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    Sorbitan Monostearate (UNII: NVZ4I0H58X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51852-103-011 in 1 BOX
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C11/01/2010
    Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)

Related Drugs