CLOTRIMAZOLE by Geritrex Corp CLOTRIMAZOLE cream

CLOTRIMAZOLE by

Drug Labeling and Warnings

CLOTRIMAZOLE by is a Otc medication manufactured, distributed, or labeled by Geritrex Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

KEEP OUT OF REACH OF CHILDREN

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

STORAGE AND HANDLING

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

DOSAGE & ADMINISTRATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54162-018
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54162-018-05	14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	07/29/2014

Labeler - Geritrex Corp (112796248)

Registrant - Geritrex Corp (112796248)

Establishment
Name	Address	ID/FEI	Business Operations
Geritrex Corp		112796248	manufacture(54162-018)