Clotrimazole by Promex, LLC CLOTRIMAZOLE cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Promex, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

• Cures most athlete's foot, jock itch, and ringworm
• Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use only

Do not use

• on children under 2 years of age except under the advice and supervision of a doctor

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

• Irritation occursThere is no improvement within 4 weeks(for athlete's foot and ringworm) or 2 weeks (for jock itch)Do not use for diaper rash

Keep out of reach of children

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

Directions

• Wash affected area and dry thoroughly
• Apply a thin layer 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 a day
• For athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
• If conditions persist longer, ask a doctor
• This product is not effective on the scalp or nails

Other information

• store between 2°and 30°C (36°and 86°F)

Inactive ingredients

Benzyl alcohol, Carbomer940, Cetyl alcohol, Glycerin, Glyceryl monostearate, Light liquid paraffin, Purified water, Stearic acid and Trolamine

PRINCIPAL DISPLAY PANEL

Clotrimazole

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58988-0022
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)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PARAFFIN (UNII: I9O0E3H2ZE)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58988-0022-1	1 in 1 BOX
1		28.35 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/04/2013

Labeler - Promex, LLC (789974388)