Label: CLOTRIMAZOLE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 November 20, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    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 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

    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 ingredient

    polyethylene glycol 400

  • Questions?

    Please Call 1-877-225-6999

  • PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton

    NDC 71399-0500-1

    Compare to the active ingredient of Lotrimin®AF*

    Clotrimazole Topical Solution USP,1%

    Antifungal

    • Relieves Itching & Burning
    • Greaseless, Nonstaining

    For External use only.
    Not for Opthalmic use.

    Keep this and all medications out of the reach of children.

    Akron Pharma

    10ml

    Label​​​

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0500
    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:71399-0500-110 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C05/15/2017
    Labeler - Akron Pharma Inc (067878881)
    Registrant - Akron Pharma Inc (067878881)
    Establishment
    NameAddressID/FEIBusiness Operations
    SLV PHARMACEUTICALS LLC081225162manufacture(71399-0500)