NDC | 54473-096-01 |
Set ID | e993fa3b-1d85-46b7-bda5-ed875be74c4e |
Category | HUMAN OTC DRUG LABEL |
Packager | Melaleuca, Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- clean 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 physician
- children under 12 years of age should be supervised 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 athletes foot and ringworm, use daily for 4 weeks: for jock itch, use daily for 2 weeks
- this product is not effective on scalp or nails
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DERMATIN ANTIFUNGAL
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54473-096 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 0.01 g in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) ALCOHOL (UNII: 3K9958V90M) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PEG-100 STEARATE (UNII: YD01N1999R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARETH-2 (UNII: V56DFE46J5) STEARETH-21 (UNII: 53J3F32P58) STEARIC ACID (UNII: 4ELV7Z65AP) TEA TREE OIL (UNII: VIF565UC2G) WATER (UNII: 059QF0KO0R) TROLAMINE (UNII: 9O3K93S3TK) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54473-096-01 14 g in 1 TUBE; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 01/01/2012 Labeler - Melaleuca, Inc. (139760102) Establishment Name Address ID/FEI Business Operations Melaleuca, Inc. 079711683 manufacture(54473-096)