CLOTRIMAZOLE ANTIFUNGAL- clotrimazole cream 
Aru Pharma 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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QPACK CLOTRIMAZOLE CREAM 1%

Drug Facts

Active ingredient

Clotrimazole USP 1%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use 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 ringworm) or 2 weeks (for jock itch)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

Inactive ingredients

Cetostearyl alcohol, Cetomacrogol 1000, Micro wax, Light liquid paraffin, Paraffin wax, Chlorocresol, Propylene Glycol, Purified water

Other information

• Do not use if seal is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal

• store at temperature not exceeding 30°C (86°F). Do not freeze. • See crimp of tube or carton for Lot Number and Expiration Date

Questions or comments?

1 844 500-2729‬ between 9 am and 4 pm EST, Monday to Friday.

Cures Most Athlete's Foot

Relieves Itching & Burning, Relieves Cracking and Scaling, Grease less, Non-Staining

Compared to the active ingredient in Lotrimin AF

Distributed by.

ARU PHARMA INC.

MOUNT VERNON, NY 10552

www.qpackrx.com

Packaging

Clotrmzle1

CLOTRIMAZOLE ANTIFUNGAL 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70403-925
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
CHLOROCRESOL (UNII: 36W53O7109)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorwhite (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70403-925-301 in 1 CARTON01/01/201803/31/2025
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/201803/31/2025
Labeler - Aru Pharma Inc. (079736192)

Revised: 5/2023
Document Id: 5ba145b6-c454-4250-8bad-282d6ac47b3b
Set id: 011e7bae-b7e1-42e3-a805-7c5ac794c252
Version: 4
Effective Time: 20230515
 
Aru Pharma Inc.