ATOPALM CLOTRIMAZOLE ANTIFUNGAL - clotrimazole cream 
NeoPharm Co., Ltd.

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.

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ATOPALM CLOTRIMAZOLE ANTIFUNGAL CREAM

Drug Facts

Active Ingredients

Clotrimazole 1%

Purpose

Antifungal

Uses

Warnings       For external use only.

Do not use on diaper rash or on children under 2 years of age unless directed by a doctor.


When using this product avoid contact with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ring worm) or 2 weeks (for jock itch).

Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other Information

Inactive Ingredients

Water, Glycerin,Cetyl Alcohol, Mineral Oil, Glyceryl Stearate, PEG Glyceryl Stearate, Stearic Acid, Benzyl Alcohol, Carbomer 940, Cholesterol, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Triethanolamine

Questions? Call 1-855-ATOPALM

US Patent US 6221371B1

Distributed by: NeoPharm Co., Ltd, 80 Wood Rd, 212 Camarillo, CA 93010

Made in Korea

Clotrimazole 1%
Antifungal
Cream

Product Labeling

image description
image description

ATOPALM CLOTRIMAZOLE ANTIFUNGAL  
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-1000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-1000-11 in 1 CARTON
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/16/2011
Labeler - NeoPharm Co., Ltd. (965502912)
Establishment
NameAddressID/FEIBusiness Operations
NeoPharm Co., Ltd.631101883manufacture(51141-1000)

Revised: 5/2015
Document Id: 23bc6028-b07e-4d84-baf6-19207ff3da37
Set id: 961de13a-b052-4903-b55e-a6b146f60af1
Version: 4
Effective Time: 20150528
 
NeoPharm Co., Ltd.