NDC | 66672-001-01, 66672-001-02 |
Set ID | b7ba4df9-2226-43fe-af6a-46afdaa7c6f5 |
Category | HUMAN OTC DRUG LABEL |
Packager | GUANGZHOU NATIONAL PHARMACEUTICAL CO LTD |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
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
-
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)