Label: HUA TUO XIAN GAO ANTIFUNGAL- 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 April 13, 2020

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 finalpart333C04/01/2020
    Labeler - MADISON ONE ACME INC (096196758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Dingtai Pharmaceutical Co., Ltd420598724manufacture(55614-650)