Label: CVS CLOTRIMAZOLE MAXIMUM STRENGTH- 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 December 26, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Clotrimazole 1%

  • Purpose

    Antifungal

  • Use

    • for the effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • Warnings

    For external use only

    Do not use

    • for diaper rash
    • on children under 2 years of age unless directed by a doctor

    When using this product

    • avoid contact with eyes

    Stop use immediately and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

  • Directions

    • wash affected area and dry thoroughly
    • use brush to 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 and change shoes and socks at least once daily
    • for athlete's foot and ringworm, use daily for 4 weeks
    • if condition persists longer, consult a doctor
    • this product is not effective on the scalp or nails
  • Other information

    • store at 15 to 30°C (59 to 86°F)
    • do not use if seal on bottle is punctured or missing
  • Inactive ingredients

    Glycine soja (soybean) oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita (peppermint) oil

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

    CVS
    Health

    Compare to the active
    ingredient in Lotrimin®AF*

    NDC 69842-866-01

    MAXIMUM STRENGTH
    Clotrimazole 1%
    ANTIFUNGAL SOLUTION

    • Kills most athlete's foot
    • Effectively relieves itching,
      burning, cracking & scaling
    • Proprietary blend of Tea Tree
      & Peppermint Oil
    • Paraben free

    Actual Bottle Size
    on Side Panel

    0.5 FL OZ (15 mL)

    PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CVS CLOTRIMAZOLE  MAXIMUM STRENGTH
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-866
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SOYBEAN OIL (UNII: 241ATL177A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-866-011 in 1 CARTON02/01/2002
    115 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333C02/01/2002
    Labeler - CVS Pharmacy (062312574)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natureplex LLC062808196MANUFACTURE(69842-866)