CLOTRIMAZOLE- clotrimazole solution 
GRAXCELL PHARMACEUTICAL, LLC.

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 (TOPICAL SOLUTION) USP, 1%, 70795-8020

DRUG FACTS

ACTIVE INGREDIENT

CLOTRIMAZOLE USP, 1%

PURPOSE

ANTIFUNGAL

USES

Cures most

Effectively relieves

Discomfort which can accompany these conditions

warnings

Ask a doctor before use

on children under 2 years of age

When using this product

avoid contact with eyes

Stop use and ask a doctorif

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a poison control center right away.

Directions

This product is not effective on the scalp or nails. For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

For athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily.

other information

inactive ingredients

polyethylene glycol 400

questions?

please call 1-888-266-8818

Graxcell clotrimazole carton 10mL

CLOTRIMAZOLE 
clotrimazole solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-8020
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:70795-8020-110 mL in 1 BOTTLE; Type 0: Not a Combination Product12/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/08/2017
Labeler - GRAXCELL PHARMACEUTICAL, LLC. (056556923)
Establishment
NameAddressID/FEIBusiness Operations
GRAXCELL PHARMACEUTICAL, LLC.056556923manufacture(70795-8020)

Revised: 12/2021
Document Id: d3add308-b070-0f99-e053-2a95a90a4e2d
Set id: 5f8ca6ad-cb25-1abf-e053-2a91aa0aca99
Version: 13
Effective Time: 20211221
 
GRAXCELL PHARMACEUTICAL, LLC.