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%

  • Purpose

    Antifungal

  • Uses:

    For the effective treatment of most:

    • athlete’s foot (tinea pedis)
    • ringworm (tinea corporis)
  • 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.

  • Inactive Ingredients:

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

  • 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.
  • Questions? Comments?

    Call 1-800-213-9370

  • PRINCIPAL DISPLAY PANEL

    Antifungal Solution  CLOTRIMAZOLE 1%

    .5 Fl. oz (15 ml)

  • Akin Antifungal Solution .5oz/15ml

    Label Image
  • INGREDIENTS AND APPEARANCE
    AKIN ANTI-FUNGAL 
    clotrimazole solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69822-254
    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
    GLYCINE (UNII: TE7660XO1C)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    MENTHA PIPERITA (UNII: 79M2M2UDA9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69822-254-051 in 1 CARTON01/01/2017
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2017
    Labeler - Southern Sales & Service, Inc. (013114906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Southern Sales & Service, Inc.013114906LABEL(69822-254)
    Establishment
    NameAddressID/FEIBusiness Operations
    GADAL Laboratories, Inc841305639MANUFACTURE(69822-254)