Label: AU KAH CHUEN ANTIFUNGAL- clotrimazole lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 66672-001-01, 66672-001-02 - Packager: GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD
- 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 May 8, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Wash the affected area and dry thoroughly.
Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor.
Supervise children in the use of this product.
For athlete’s foot:
Pay special attention to spaces 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 - STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AU KAH CHUEN ANTIFUNGAL
clotrimazole lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66672-001 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 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL ALCOHOL (UNII: ND2M416302) MUSK XYLENE (UNII: 1ZAO16GU5K) PHENOL (UNII: 339NCG44TV) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66672-001-01 1 in 1 BOX 05/08/2017 1 24 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product 2 NDC:66672-001-02 1 in 1 BOX 05/08/2017 2 12 mL in 1 BOTTLE, WITH APPLICATOR; 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 05/08/2017 Labeler - GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD (547447953) Establishment Name Address ID/FEI Business Operations GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD 547447953 manufacture(66672-001)
