Label: HUA TUO XIAN GAO ANTIFUNGAL- clotrimazole ointment
- NDC Code(s): 55614-650-01
- Packager: MADISON ONE ACME INC
- Category: HUMAN OTC DRUG LABEL
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
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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
-
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 final 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)