CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [ARU PHARMA INC.]

CLOTRIMAZOLE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [ARU PHARMA INC.]
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NDC 70403-925-30
Set ID 011e7bae-b7e1-42e3-a805-7c5ac794c252
Category HUMAN OTC DRUG LABEL
Packager Aru Pharma Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Drug Facts

  • Active ingredient

    Clotrimazole USP 1%

  • 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 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 ringworm) or 2 weeks (for jock itch)

  • 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. (1-800-222-1222)

  • Directions

    • wash the affected area and dry thoroughly
    • apply a 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 the 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 condition persists longer, consult a doctor
    • this product is not effective on the scalp or nails
  • Inactive ingredients

    Cetostearyl alcohol, Cetomacrogol 1000, Micro wax, Light liquid paraffin, Paraffin wax, Chlorocresol, Propylene Glycol, Purified water

  • Other information

    • Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal

    • store at temperature not exceeding 30°C (86°F). Do not freeze. • See crimp of tube or carton for Lot Number and Expiration Date

  • Questions or comments?

    1 844 500-2729‬ between 9 am and 4 pm EST, Monday to Friday.

  • SPL UNCLASSIFIED SECTION

    Cures Most Athlete's Foot

    Relieves Itching & Burning, Relieves Cracking and Scaling, Grease less, Non-Staining

    Compared to the active ingredient in Lotrimin AF

    Distributed by.

    ARU PHARMA INC.

    MOUNT VERNON, NY 10552

    www.qpackrx.com

  • Packaging

    Clotrmzle1

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE ANTIFUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-925
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 (UNII: I835H2IHHX)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Colorwhite (white to off white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70403-925-301 in 1 CARTON01/01/2018
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2018
    Labeler - Aru Pharma Inc. (079736192)

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