CLOTRIMAZOLE SOLUTION [AKRON PHARMA INC]

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CLOTRIMAZOLE SOLUTION [AKRON PHARMA INC]
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NDC 71399-0500-1
Set ID 692d7e0f-50d4-4abb-8c74-36bc98064fe7
Category HUMAN OTC DRUG LABEL
Packager Akron Pharma Inc
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • 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)
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