Label: CLOTRIMAZOLE cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 51852-103-01 - Packager: LIFElabs, a Division of Atico International USA, INC.
- 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 23, 2010
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Clotrimazole
- PURPOSE
- WARNINGS
- INDICATIONS & USAGE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
- for athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
- if conditions persist longer, ask a doctor
- this product is not effective on the scalp or nails
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51852-103 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 Benzyl Alcohol (UNII: LKG8494WBH) Isopropyl Myristate (UNII: 0RE8K4LNJS) Mineral Oil (UNII: T5L8T28FGP) Polysorbate 60 (UNII: CAL22UVI4M) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Stearic Acid (UNII: 4ELV7Z65AP) Stearyl Alcohol (UNII: 2KR89I4H1Y) Sorbitan Monostearate (UNII: NVZ4I0H58X) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51852-103-01 1 in 1 BOX 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 11/01/2010 Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)