Label: AKIN ANTI-FUNGAL- clotrimazole solution

  • NDC Code(s): 69822-254-05
  • Packager: Southern Sales & Service, Inc.
  • 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 January 1, 2017

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

  • Active Ingredient

    Clotrimazole 1%

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  • Purpose

    Antifungal

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  • Uses:

    For the effective treatment of most:

    • athlete’s foot (tinea pedis)
    • ringworm (tinea corporis)
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  • Warnings:

    For external use only

    When Using This Product

    avoid contact with eyes

    Stop Use If:

    • irritation occurs
    • there is no improvement within 4 weeks.

    KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poison Control Center immediately.

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  • Inactive Ingredients:

    Glycine Soja (Soybean) Oil, Melaleuca Alternifolia (tea tree) leaf oil, Mentha Piperita.

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  • Directions:

    Read all package directions and warnings before using.

    • Wash affected area and dry thoroughly.
    • Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
    • For athlete’s foot: pay special attention to spaces between 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.
    • Supervise children in the use of this product.
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  • Questions? Comments?

    Call 1-800-213-9370

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  • PRINCIPAL DISPLAY PANEL

    Antifungal Solution  CLOTRIMAZOLE 1%

    .5 Fl. oz (15 ml)

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  • Akin Antifungal Solution .5oz/15ml
  • INGREDIENTS AND APPEARANCE
    AKIN ANTI-FUNGAL 
    clotrimazole solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69822-254
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCINE (UNII: TE7660XO1C)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69822-254-05 1 in 1 CARTON 01/01/2017
    1 15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 01/01/2017
    Labeler - Southern Sales & Service, Inc. (013114906)
    Establishment
    Name Address ID/FEI Business Operations
    Southern Sales & Service, Inc. 013114906 LABEL(69822-254)
    Establishment
    Name Address ID/FEI Business Operations
    GADAL Laboratories, Inc 841305639 MANUFACTURE(69822-254)
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