CLOTRIMAZOLE ANTIFUNGAL- clotrimazole cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Actavis Pharma, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Clotrimazole, USP 1%

Purpose

Antifungal

Uses

cures most athlete’s foot, jock itch, and ringworm   relieves itching, burning, cracking, scaling, and discomfort

Warnings

For external use only

Do not use

on children under 2 years, unless directed by a doctor.

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

irritation occurs    there is no improvement within 4 weeks (for athlete’s foot and ringworm) or within 2 weeks (for jock itch)

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wash 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 product
• for athlete’s foot:pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
• for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
• if condition last longer, contact a doctor
• this product is not effective on the scalp or nails

Other information

Store between 2o-30oC (36o – 86oF).  Before using any medication, read all label directions.  Keep carton, it contains important information.

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Principal Display Panel

Actavis
NDC: 0472-0350-56
Compare to the active ingredient in Lotrimin® AF* 

Clotrimazole Cream, USP 1%
Antifungal
Cures Most Athlete’s Foot
Relieves: Itching │ Burning │ Cracking │ Scaling 

Net wt. 1 oz (28 g)

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE  ANTIFUNGAL
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0472-0350
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0472-0350-56	1 in 1 CARTON	01/03/2017
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	01/03/2017

Labeler - Actavis Pharma, Inc. (119723554)