CLOTRIMAZOLE- clotrimazole cream 
Geritrex Corp

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 Cream 1%

Drug Facts

Active Ingredient:             Purpose

Clotrimazole 1%            Antifungal

Uses

Treats most athlet's foot, jock itch and ringworm, relieves itching, scaling, burning, irritation, and discomfort

Directions

Clean the affected area and dry thoroughly Apply a thin layer of the product over affected area twice daily(morning and night), or as directed by a doctor Supervise children in the use of this products.This products does not work on the scalp or nail. For athlet's foot and ringworm pay special attention to spaces between the toes: wear well fitting, ventilates shoes, and change shoes and socks at least once every day. Use every day for 4 weeks. For jock itch, use every day for 2 weeks. If condition lasts longer, contact a doctor.

Warnings

FOR EXTERNAL USE ONLY

When using this product do not get in to the eyes. Stop use and ask doctor if irritation occurs there is no improvement within 4 weeks (for athlet's foot or ringworm) or within 2 weeks (for jock itch). Do not use on children under 2 years, unless directed by a doctor.

Inactive Ingredients

Benzyl alcohol, Cetearth 20, Cetyl alcohol, Citric acid, Paraffin wax, Petrolatum, Polysorbate 80, Sodium citrate, Sorbitan sesquioleate, Stearyl alcohol, Water

KEEP OUT OF REACH OF CHILDREN

In the event of accidental ingestion, contact a Poison Control Center right away.

Store between 20'-30'C (36'-86'F)

Use every day for 4 weeks. For jock itch, use every day for 2 weeks. if conditon lasts longer, contact a doctor

Label of tube

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-018
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETEARETH-2 PHOSPHATE (UNII: 8NSU66JGZR)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-018-0514 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/29/2014
Labeler - Geritrex Corp (112796248)
Registrant - Geritrex Corp (112796248)
Establishment
NameAddressID/FEIBusiness Operations
Geritrex Corp112796248manufacture(54162-018)

Revised: 7/2014
Document Id: ce329877-f502-4829-8609-553bc3259aa1
Set id: 81811256-9c92-4c24-a662-d07b20a7f833
Version: 1
Effective Time: 20140729
 
Geritrex Corp