Label: SOUNDBODY CLOTRIMAZOLE ANTIFUNGAL- clotrimazole cream
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Contains inactivated NDC Code(s)
NDC Code(s): 65923-139-28 - Packager: United Exchange Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 July 5, 2017
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- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- 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 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
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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)