CLOTRIMAZOLE- clotrimazole cream 
Kareway Product, Inc.

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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Soundbody Clotrimazole

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

butylated hydroxytoluene, carbomer 940, cetyl alcohol, ethylparaben, glycerin, glyceryl stearate, propylene glycol, sodium lauryl sulfate, stearic acid, water

Clotrimazole

carton

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0638
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
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ETHYLPARABEN (UNII: 14255EXE39)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0638-11 in 1 BOX08/27/2018
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/11/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 2/2023
Document Id: f4eec334-ed72-ea33-e053-2a95a90a12fd
Set id: 74793b07-9428-addc-e053-2a91aa0ae2b1
Version: 4
Effective Time: 20230217
 
Kareway Product, Inc.