CLOTRIMAZOLE CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]

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CLOTRIMAZOLE CREAM [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
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NDC 50382-025-13
Set ID 6c09bb74-150d-4823-85c2-ba451c1c29ff
Category HUMAN OTC DRUG LABEL
Packager Galentic Pharma (India) Private Limited
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • • ACTIVE INGREDIENT

    Active Ingredient
    Clotrimazole 1.0%

  • Purpose

    Antifungal

  • • USES

    • Cures most athlete's foot, jock itch and ringworm
    • Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions
  • • 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 this product avoid contact with eyes

    • Stop use and ask doctor if

    • Irritation occurs
    • There is no improvement in 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

    • KEEP OUT OF REACH OFCHILDREN

      If swallowed, get medical help or contact a Poison Control Center immediately.

  • • DIRECTIONS

    • Wash affected area and dry thoroughly
    • Apply thin layer over affected area twice daily (morning and night)
    • 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 daily
    • For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
    • If conditions persists longer, ask a doctor
    • This product is not effective on scalp or nails.
  • • OTHER INFORMATION

    • Store between 15° and 30° C (59° and 86°F)
    • Lot No. & Exp. Date: See box or crimp of tube.
  • • INACTIVE INGREDIENTS

    Cetomacrogol 1000, Cetostearyl alcohol, Liquid paraffin, Methylparaben, Propylene glycol, Propylparaben, Purified water, White soft paraffin

  • SPL UNCLASSIFIED SECTION

    Manufactured by : Galentic Pharma (India) Pvt. Ltd., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone,

    Gandhidham-370 230, Gujarat. India

  • PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

    Galentic

    Clotrimazole
    Cream
    ANTIFUNGAL

    Relieves
    itching, burning, cracking & scaling
    Cures most Athlete's Foot

    NET WT.
    1 OZ. (28g)

    PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-025
    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
    CETETH-20 (UNII: I835H2IHHX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-025-131 in 1 CARTON08/07/2013
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/07/2013
    Labeler - Galentic Pharma (India) Private Limited (915110464)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Private Limited650970176analysis(50382-025) , manufacture(50382-025) , pack(50382-025) , repack(50382-025) , sterilize(50382-025)
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