CVS CLOTRIMAZOLE MAXIMUM STRENGTH (CLOTRIMAZOLE) SOLUTION [CVS PHARMACY]

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CVS CLOTRIMAZOLE MAXIMUM STRENGTH (CLOTRIMAZOLE) SOLUTION [CVS PHARMACY]
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NDC 69842-866-01
Set ID c4feae92-e7a0-4abc-aa4e-72b8ae00f501
Category HUMAN OTC DRUG LABEL
Packager CVS Pharmacy
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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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)
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