Label: HEALTHY ACCENTS ANTIFUNGAL- clotrimazole cream
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Contains inactivated NDC Code(s)
NDC Code(s): 55316-829-28 - Packager: DZA Brands LLC
- Category: HUMAN OTC DRUG LABEL
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 August 3, 2016
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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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 chagne 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 condtion persists longer, ask a doctor
- this product is not effectiveo n the scalp or nails
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HEALTHY ACCENTS ANTIFUNGAL
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-829 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 10 g in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CETYL ALCOHOL (UNII: 936JST6JCN) PARAFFIN (UNII: I9O0E3H2ZE) OCTYLDODECANOL (UNII: 461N1O614Y) POLYSORBATE 60 (UNII: CAL22UVI4M) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) STEARIC ACID (UNII: 4ELV7Z65AP) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55316-829-28 1 in 1 CARTON 08/03/2016 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 07/26/2016 Labeler - DZA Brands LLC (090322194)