Clotrimazole Cream [Taro Pharmaceuticals, Inc.] -

CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS, INC.]
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NDC	61360-2002-1, 61360-2002-2, 61360-2002-3
Set ID	00b35b4e-848b-4477-a735-2f88a16af9ef
Category	HUMAN OTC DRUG LABEL
Packager	Taro Pharmaceuticals, Inc.
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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Drug Facts
Active ingredient

Clotrimazole 1%
Purpose

Antifungal
Uses
- cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
- for effective relief of
- itching
- scaling
- cracking
- burning
- redness
- soreness
- irritation
- discomfort
Warnings
For external use only
Ask a doctor before use
- on children under 2 years of age
When using this product
- avoid contact with 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
This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
- clean 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; change shoes and socks at least once daily
Other information
- To open: unscrew cap, use the pointed end of cap to puncture seal.
- store between 2°- 30°C (36° - 86°F)
- see carton or tube crimp for lot number and expiration date
Inactive ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate
Questions?

Call 1-866-923-4914
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Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532
PRINCIPAL DISPLAY PANEL - 15 g Carton

Cures Most Athlete's Foot

Athlete's Foot
Cream
Clotrimazole Cream USP,1%
Antifungal Cream

Antifungal Cream

NET WT (1/2 oz) 15 g

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61360-2002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65)	Clotrimazole	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
benzyl alcohol (UNII: LKG8494WBH)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetyl esters wax (UNII: D072FFP9GU)
polysorbate 60 (UNII: CAL22UVI4M)
water (UNII: 059QF0KO0R)
sorbitan monostearate (UNII: NVZ4I0H58X)

#	Item Code	Package Description
Packaging
1	NDC:61360-2002-1	1 in 1 CARTON
1		15 g in 1 TUBE
2	NDC:61360-2002-2	1 in 1 CARTON
2		30 g in 1 TUBE
3	NDC:61360-2002-3	1 in 1 CARTON
3		60 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333C	06/01/1995

Labeler - Taro Pharmaceuticals, Inc. (206263295)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE

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CLOTRIMAZOLE CREAM [TARO PHARMACEUTICALS, INC.]

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