Label: HUA TUO XIAN GAO ANTIFUNGAL- clotrimazole ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 25, 2024

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
    ■ if pregnant
    ■ if nursing
    ■ on children under 12 years of age unless directed by a doctor

  • 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 flower oil, petrolatum, salicylic acid, and yellow wax.

  • 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

    Clotrimazole 1.0%

    Cure Athlete’s Foot Jock Itch & Ringworm

    NDC 55614-650-01

    20 g (0.7 oz)

    Odorless

    Non-Greasy

    box-01.jpg
    box-01.jpg

  • INGREDIENTS AND APPEARANCE
    HUA TUO XIAN GAO ANTIFUNGAL 
    clotrimazole ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55614-650
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CHIMONANTHUS PRAECOX FLOWER OIL (UNII: EB4HIB5MLF)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55614-650-011 in 1 BOX04/01/2020
    120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drugpart333C04/01/2020
    Labeler - MADISON ONE ACME INC (096196758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-650)