CLOTRIMAZOLE- clotrimazole solution 
The Podiatree Company

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.

----------

Clotrimazole Topical Solution USP,1%

Drug Facts

Active ingredient

Clotrimazole 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 eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wash affected area and dry thoroughly

• apply to the affected area twice daily (morning and night) or as directed by your 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

• for athlete’s foot and ringworm infections, use daily for 4 weeks

• if condition persists longer, consult your doctor

Other information

Inactive ingredient

polyethylene glycol

Questions?

1-855-763-8733

Manufactured for

The Podiatree Company, Holbrook, NY 11741

Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 10 mL Carton



carton

CLOTRIMAZOLE 
clotrimazole solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54633-018
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE1 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54633-018-101 in 1 CARTON03/30/2018
110 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/30/2018
Labeler - The Podiatree Company (078656000)

Revised: 3/2018
Document Id: 68a4ed34-f491-67a6-e053-2a91aa0a0428
Set id: 68a4e3f5-f84d-5650-e053-2a91aa0a171d
Version: 1
Effective Time: 20180330
 
The Podiatree Company