NDC | 63868-104-46 |
Set ID | 684e9447-e16e-42e2-b268-e37b48eb2e92 |
Category | HUMAN OTC DRUG LABEL |
Packager | Chain Drug Marketing Association Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- WHEN USING
- STOP USE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
Directions
- wash affected area and dry thoroughly
- apply a thin layer over 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 space between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least one daily
- use daily for 4 weeks; if condition persists longer, ask a doctor
- 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
- wash affected area and dry thoroughly
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE TOLNAFTATE ANTIFUNGAL
tolnaftate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MINERAL OIL (UNII: T5L8T28FGP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) CETYL ALCOHOL (UNII: 936JST6JCN) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) WATER (UNII: 059QF0KO0R) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-104-46 1 in 1 CARTON 05/31/2013 1 30 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 05/31/2013 Labeler - Chain Drug Marketing Association Inc (011920774)