NDC | 65923-139-28 |
Set ID | 3bfeaf9a-cdcc-4875-ba4d-613e834acb4c |
Category | HUMAN OTC DRUG LABEL |
Packager | United Exchange Corp. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- STOP 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)
- 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, and change shoes and socks at least once a day
- for athlete's foot and ringwom use daily for 4 weeks; for jock itch; use daily for 2 weeks
- this product is not effective on the scalp or nails
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SOUNDBODY CLOTRIMAZOLE ANTIFUNGAL
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-139 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength OCTYLDODECANOL (UNII: 461N1O614Y) BENZYL ALCOHOL (UNII: LKG8494WBH) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL ESTERS WAX (UNII: D072FFP9GU) MAGNESIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: H3992158BT) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65923-139-28 1 in 1 BOX 10/04/2016 1 28 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 02/26/2014 Labeler - United Exchange Corp. (840130579)