APTRIMAZOLE 1.0% ANTIFUNGAL CREAM- clotrimazole cream 
A P J Laboratories Limited

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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CLOTRIMAZOLE

Antifungal


Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Cures most athlete's foot, jock itch, and ringworm.

Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.



Do not use:

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

Avoid contact with eyes.

For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.







Direction:

Clean the affected area and dry thoroughly. Apply a layer of cream 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 daily.

Foe athlete's foot and ringworm, use daily for 4 weeks.

For jock itch, use daily for 2 weeks.

If conditions persist longer, consult a doctor.

This product is not effective on scalp or nails.




PETROLATUM

LIGHT MINERAL OIL

CETOSTEARYL ALCOHOL

EDETIC ACID

CHLOROCRESOL

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

POLYSORBATE 60

CETETH-20

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product
APTRIMAZOLE  1.0% ANTIFUNGAL CREAM
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46084-081
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
PETROLATUM (UNII: 4T6H12BN9U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETIC ACID (UNII: 9G34HU7RV0)  
CHLOROCRESOL (UNII: 36W53O7109)  
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CETETH-20 (UNII: I835H2IHHX)  
Product Characteristics
Colorwhite (offwhite) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46084-081-3115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/27/2013
Labeler - A P J Laboratories Limited (677378339)
Registrant - A P J Laboratories Limited (677378339)
Establishment
NameAddressID/FEIBusiness Operations
A P J Laboratories Limited677378339manufacture(46084-081)

Revised: 4/2013
Document Id: 8ef19bfe-6e70-4aed-979b-274315278c63
Set id: b54ff8e9-ea77-4702-8c2f-4c693df45547
Version: 1
Effective Time: 20130427
 
A P J Laboratories Limited