Clotrimazole Cream [Central Texas Community Health Centers] -

CLOTRIMAZOLE CREAM [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]
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NDC	76413-351-30
Set ID	01b1b76f-0c11-437f-82b5-931670c27a8d
Category	HUMAN OTC DRUG LABEL
Packager	Central Texas Community Health Centers
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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SPL UNCLASSIFIED SECTION

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
HOW SUPPLIED

Product: 76413-351

NDC: 76413-351-30 30 g in a TUBE / 1 in a CARTON
CLOTRIMAZOLE CREAM

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76413-351(NDC:51672-2002)
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)

Product Characteristics
Color	WHITE (Smooth)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:76413-351-30	1 in 1 CARTON	06/07/2018
1		30 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	06/01/1995

Labeler - Central Texas Community Health Centers (079674019)

Name	Address	ID/FEI	Business Operations
Establishment
Travis County Healthcare District		797039398	RELABEL(76413-351) , REPACK(76413-351)

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Medic

CLOTRIMAZOLE CREAM [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]

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