Label: ATOPALM CLOTRIMAZOLE ANTIFUNGAL- clotrimazole cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51141-1000-1 - 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 May 28, 2015
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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 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 condition persists longer, ask a doctor
- this product not effective on the scalp or nails
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Product Labeling
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INGREDIENTS AND APPEARANCE
ATOPALM CLOTRIMAZOLE ANTIFUNGAL
clotrimazole creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51141-1000 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 WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) MINERAL OIL (UNII: T5L8T28FGP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARIC ACID (UNII: 4ELV7Z65AP) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) CHOLESTEROL (UNII: 97C5T2UQ7J) MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51141-1000-1 1 in 1 CARTON 1 28.3 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 03/16/2011 Labeler - NeoPharm Co., Ltd. (965502912) Establishment Name Address ID/FEI Business Operations NeoPharm Co., Ltd. 631101883 manufacture(51141-1000)