CLOTRIMAZOLE ANTIFUNGAL- clotrimazole solution 
Trifecta Pharmaceuticals USA, LLC.

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Globe Clotrimazole (Topical Solution) USP 1%

Active Ingredient

Clotrimazole USP, 1.0%

Purpose

Antifungal

Uses

Cures most

Effectively relieves

Discomfort that can accompany these conditions

Warnings

For External Use Only

Stop use and ask a doctor

Ask a Doctor before use

Ask a doctor before use on children under 2 years of age

When using this product

Avoid Contact with Eyes.

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

Other information

Inactive Ingredients

Ethanol, Propylene glycol, purified water

Questions or Comments

Call 1-888-296-9067

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

Globe® Clotrimazole anti-fungal solution is not manufactured or distributed by Bayer, owner of the registered trademark Lotrimin®AF.

Packaging

4310 GLOBE CLOTRIMAZOLE SOLUTION 1 percent 10ML 110723 CDER FILE

CLOTRIMAZOLE ANTIFUNGAL 
clotrimazole solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-143
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-143-331 in 1 BOX11/13/2023
10.01 L in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00511/13/2023
Labeler - Trifecta Pharmaceuticals USA, LLC. (079424163)

Revised: 2/2024
Document Id: 11bf503d-be71-0b75-e063-6394a90aa94e
Set id: 11bf50db-552e-0a39-e063-6394a90af60d
Version: 1
Effective Time: 20240219
 
Trifecta Pharmaceuticals USA, LLC.