CLOTRIMAZOLE SOLUTION [GRAXCELL PHARMACEUTICAL, LLC.]

CLOTRIMAZOLE SOLUTION [GRAXCELL PHARMACEUTICAL, LLC.]
PDF | XML

NDC 70795-8020-1
Set ID 5f8ca6ad-cb25-1abf-e053-2a91aa0aca99
Category HUMAN OTC DRUG LABEL
Packager GRAXCELL PHARMACEUTICAL, LLC.
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 (tinea pedis)
    • Jock Itch (tinea cruris)
    • Ringworm (tinea corporis)

    Effectively relieves

    • itching
    • cracking
    • burning

    Discomfort which can accompany these conditions

  • warnings

    • For external use only

    Ask a doctor before use

    on children under 2 years of age

    When using this product

    avoid contact with eyes

    Stop use and ask a doctorif

    • 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

    If swallowed, get medical help or contact a poison control center right away.

  • Directions

    This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

    • clean the affected area and dry thoroughly
    • apply a thin layer of the product 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; change shoes and socks at least once daily.

  • other information

    • Store at 15°to 30°C (59° to 86°F)

  • inactive ingredients

    polyethylene glycol 400

  • questions?

    please call 1-888-266-8818

  • PRINCIPAL DISPLAY PANEL

    Graxcell clotrimazole carton 10mL

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-8020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70795-8020-110 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/08/2017
    Labeler - GRAXCELL PHARMACEUTICAL, LLC. (056556923)

Related Drugs