EQUALINE CLOTRIMAZOLE ANTIFUNGAL- clotrimazole cream

EQUALINE CLOTRIMAZOLE ANTIFUNGAL by

Drug Labeling and Warnings

EQUALINE CLOTRIMAZOLE ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by SUPERVALU INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                           Purpose

Clotrimazole 1% ........................................................................Antifungal

ACTIVE INGREDIENT

Active ingredient                                                                           Purpose

Clotrimazole 1% ........................................................................Antifungal

PURPOSE

Uses

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

WARNINGS

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor

For external use only

WHEN USING

When using this product avoid contact with the eyes

STOP USE

Stop use and ask a doctor if

• irritation occurs
  
• there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (jock itch)
• do not use for diaper rash
  

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

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 sock 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
  

STORAGE AND HANDLING

Other information

Store between 20 o to 25 oC (68 o to 77 oF)

Lot No. and Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

benzyl alcohol, cetanol, liquid paraffin, octyldodecanol, polysorbate 60, propylene glycol, purified water, sodium hydroxide, sorbitan monostearate, stearic acid, stearyl alcohol

DOSAGE & ADMINISTRATION

DISTRIBUTED BY

SUPERVALU INC

EDEN PRAIRIE,

MN 55344 USA

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EQUALINE CLOTRIMAZOLE ANTIFUNGAL 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41163-264
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)
PARAFFIN (UNII: I9O0E3H2ZE)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41163-264-69	1 in 1 CARTON	09/29/2011
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 41163-264-68	1 in 1 CARTON	09/29/2011
2		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	09/29/2011

Labeler - SUPERVALU INC (006961411)