AU KAH CHUEN ANTIFUNGAL (CLOTRIMAZOLE) LOTION [GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD]

AU KAH CHUEN ANTIFUNGAL (CLOTRIMAZOLE) LOTION [GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD]
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NDC 66672-001-01, 66672-001-02
Set ID b7ba4df9-2226-43fe-af6a-46afdaa7c6f5
Category HUMAN OTC DRUG LABEL
Packager GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Active Ingredient
    Clotrimazole 1.0%

  • PURPOSE

    Purpose
    Antifungal

  • INDICATIONS & USAGE

    Uses
    Proven clinically effective in the treatment of most:
    athlete’s foot
    jock itch
    ringworm

  • WARNINGS

    Warnings
    For external use only

    Flammable
    Keep away from fire or flame.

    Do not use on children under 2 years of age unless directed by a doctor.

  • WHEN USING

    When using this product avoid contact with the eyes.

  • STOP USE

    Stop use and ask a doctor if
    irritation occurs
    there is no improvement within:
       2 weeks when used for jock itch
       4 weeks when used for athlete’s foot or ringworm

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions
    Wash the 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.
    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.
    For athlete’s foot and ringworm: use daily for 4 weeks.
    For jock itch: use daily for 2 weeks.
    If condition persists longer, consult a doctor.
    This product is not effective on the scalp or nails

  • STORAGE AND HANDLING

    Keep container tightly closed, away from heat
    Store at 2° to 30° C (36° to 86° F)

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Glycerin, isopropyl alcohol, musk xylol, phenol and purified water.

  • QUESTIONS

    Questions or Comments? (888) 221-3496 M-F, 9am to 5pm
    you may also report serious side effects to the phone number.

  • PRINCIPAL DISPLAY PANEL

    AU KAH CHUEN ANTIFUNGAL LOTION
    NDC 66672-001-01
    0.81 fl oz (24 mL)
    IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    AU KAH CHUEN ANTIFUNGAL 
    clotrimazole lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66672-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    MUSK XYLENE (UNII: 1ZAO16GU5K)  
    PHENOL (UNII: 339NCG44TV)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66672-001-011 in 1 BOX05/08/2017
    124 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    2NDC:66672-001-021 in 1 BOX05/08/2017
    212 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 finalpart333C05/08/2017
    Labeler - GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD (547447953)
    Establishment
    NameAddressID/FEIBusiness Operations
    GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD547447953manufacture(66672-001)

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