Antifungal (Clotrimazole) Cream [Rite Aid] -

ANTIFUNGAL (CLOTRIMAZOLE) CREAM [RITE AID]
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NDC	11822-0351-3
Set ID	5ee757e9-83eb-4829-838b-0db8fd5caa20
Category	HUMAN OTC DRUG LABEL
Packager	Rite Aid Corporation
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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Drug Facts
Active ingredient

Clotrimazole, USP 1%
Purpose

Antifungal
Uses

• cures most jock itch • relieves itching, burning, scaling, discomfort, and chafing associated with jock itch
Warnings

For external use only

Do not use on children under 2 years of age, 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 2 weeks

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
• use daily for 2 weeks
• if condition lasts longer, ask a doctor
• this product is not effective on the scalp or nails
Other Information

• Store between 2°-30°C (36°-86°F).
• 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

NDC 11822-0351-3
*Compare to the active ingredient in Lotrimin® AF
antifungal cream
clotrimazole cream, USP 1%
cures most jock itch
relieves itching, burning,
scaling and chafing

NET WT 0.5 OZ (14 g)

INGREDIENTS AND APPEARANCE

ANTIFUNGAL
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-0351
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-0351-3	1 in 1 CARTON	04/15/2011
1		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333C	04/15/2011

Labeler - Rite Aid Corporation (014578892)

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Medic

ANTIFUNGAL (CLOTRIMAZOLE) CREAM [RITE AID]

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