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 August 19, 2021

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  • Active ingredient

    Clotrimazole USP, 1%

  • Purpose

    Antifungal

  • Uses

    Cures most

    • Athlete’s foot (tinea pedis),
    • Jock itch (tinea cruris), and
    • Ringworm (tinea corporis).

    Effective relieves

    • itching

    • cracking

    • burning

    • discomfort which can accompany these conditions

  • Warning

    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 the 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 between 15°-30°C (59°-86°F)

  • Inactive ingredient

    polyethylene glycol

  • Questions or comments?

    Call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

  • Clotrimazole 1% Topical Solution

    10 mL

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1181
    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:0536-1181-7010 mL in 1 BOTTLE; Type 0: Not a Combination Product08/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/20/2018
    Labeler - RUGBY LABORATORIES (079246066)
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