Label: HUA TUO XIAN GAO- clotrimazole ointment

  • 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 October 15, 2018

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

  • ACTIVE INGREDIENT


    Active ingredient
    Clotrimazole 1.0%

  • PURPOSE

    Purpose
    Antifungal

  • INDICATIONS & USAGE

    Uses

    For the cure of:
    athlete’s foot
    jock itch
    ringworm

    Relieves:
    itching
    scaling
    cracking
    burning
    discomfort
    soreness
    irritation
    redness

  • WARNINGS

    Warnings
    For external use only

  • DO NOT USE

    Do not use
    on children under 12 years of age unless directed by a doctor
    if pregnant
    if nursing

  • WHEN USING

    When using this product
    avoid contact with the eyes
    do not use the following on the skin:
    soap
    alcohol
    hydrogen peroxide
    iodine or sulphur compounds

  • 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
    Adults and children 12 years of age or older:
    Wash the affected area and dry thoroughly. In areas where the skin is thickened, soak in warm water to soften it first
    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 the toes. It is useful to apply at night on cotton balls wedged 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.
    Children under 12 years: Do not use unless directed by a doctor

  • STORAGE AND HANDLING

    Other information
    keep container tightly closed
    store between 2º and 30º C (36º to 86º F)

  • INACTIVE INGREDIENT

    Inactive ingredients
    Benzoic acid, camphor, Chimonanthus praecox (L.) Link. flower oil, insect wax (cera chinensis), petrolatum, and salicylic acid.

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    HUA TUO XIAN GAO Antifungal Ointment NDC 76182-001-01  20 g (0.7 oz)IMAGE OF CARTON

  • INGREDIENTS AND APPEARANCE
    HUA TUO XIAN GAO 
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76182-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76182-001-0120 g in 1 TUBE; Type 0: Not a Combination Product04/28/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/28/2011
    Labeler - SHANGHAI SONGHUA PHARMACEUTICAL CO LTD (420355463)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHANGHAI SONGHUA PHARMACEUTICAL CO LTD420355463manufacture(76182-001)