Label: CLOTRIMAZOLE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51141-0657-1 - Packager: NeoPharm Co., Ltd.
- 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 August 23, 2010
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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Directions
- wash affected area and dry thoroughly
- apply a thin layer cover 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
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CLOTRIMAZOLE
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51141-0657 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole 1 g in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PARAFFIN (UNII: I9O0E3H2ZE) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51141-0657-1 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 09/02/2010 Labeler - NeoPharm Co., Ltd. (631101883) Registrant - NeoPharm Co., Ltd. (631101883) Establishment Name Address ID/FEI Business Operations NeoPharm Co., Ltd. 631101883 manufacture