APTRIMAZOLE 1.0% ANTIFUNGAL CREAM- clotrimazole cream

APTRIMAZOLE by

Drug Labeling and Warnings

APTRIMAZOLE by is a Otc medication manufactured, distributed, or labeled by A P J Laboratories Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

CLOTRIMAZOLE

PURPOSE

Antifungal

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Cures most athlete's foot, jock itch, and ringworm.

Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.

Do not use:

Do not use on children under 2 years of age unless directed by a doctor.

Avoid contact with eyes.

For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Direction:

Clean the affected area and dry thoroughly. Apply a layer of cream over affected area twice daily (morning and night) or as directed by a 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.

Foe athlete's foot and ringworm, use daily for 4 weeks.

For jock itch, use daily for 2 weeks.

If conditions persist longer, consult a doctor.

This product is not effective on scalp or nails.

INACTIVE INGREDIENT

PETROLATUM

LIGHT MINERAL OIL

CETOSTEARYL ALCOHOL

EDETIC ACID

CHLOROCRESOL

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

POLYSORBATE 60

CETETH-20

DISPLAY PANEL

INGREDIENTS AND APPEARANCE

APTRIMAZOLE  1.0% ANTIFUNGAL CREAM
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46084-081
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
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
EDETIC ACID (UNII: 9G34HU7RV0)
CHLOROCRESOL (UNII: 36W53O7109)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CETETH-20 (UNII: I835H2IHHX)

Product Characteristics
Color	white (offwhite)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46084-081-31	15 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/27/2013

Labeler - A P J Laboratories Limited (677378339)

Registrant - A P J Laboratories Limited (677378339)

Establishment
Name	Address	ID/FEI	Business Operations
A P J Laboratories Limited		677378339	manufacture(46084-081)