Label: HUA TUO XIAN GAO ANTIFUNGAL- clotrimazole ointment
- NDC Code(s): 55614-650-01
- Packager: MADISON ONE ACME INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 25, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HUA TUO XIAN GAO ANTIFUNGAL
clotrimazole ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55614-650 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 1 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:55614-650-01 1 in 1 BOX 04/01/2020 1 20 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug part333C 04/01/2020 Labeler - MADISON ONE ACME INC (096196758) Establishment Name Address ID/FEI Business Operations Zhejiang Dingtai Pharmaceutical Co., Ltd 420598724 manufacture(55614-650)