Major Clotrimazole (Clotrimazole) Cream [A-S Medication Solutions] -

MAJOR CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [A-S MEDICATION SOLUTIONS]
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NDC	50090-2570-0
Set ID	cdf2b914-3b15-47c1-b54d-d961a2406507
Category	HUMAN OTC DRUG LABEL
Packager	A-S Medication Solutions
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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SPL UNCLASSIFIED SECTION

Drug Facts
Active ingredient

Clotrimazole USP 1% w/w
Purpose

Antifungal Cream
Uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.
Warnings
- Do not use on children under 2 years of age unless directed by a doctor.
- For external use only.
- Avoid contact with eyes.
- If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.
- Keep this and all drugs out of the reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
- Clean the affected area and dry thoroughly.
- Apply a thin layer of this 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 the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.
- For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
- If conditions persists longer, consult a doctor.
- This product is not effective on the scalp or nails.
Other information
- Store at controlled room temperature 15°-30°C (59°-86°F).
- Close cap tightly after use.
Inactive ingredients

aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water
Questions?

Adverse Drug Event call (800)616-2471
Dist. By MAJOR PHARMACEUTICALS
31778 Enterprise Drive, Livonia, Ml 48150 USA
Re-Oder No. 100431
HOW SUPPLIED

Product: 50090-2570

NDC: 50090-2570-0 28.35 g in a TUBE / 1 in a CARTON
CLOTRIMAZOLE

INGREDIENTS AND APPEARANCE

MAJOR CLOTRIMAZOLE
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50090-2570(NDC:0904-7822)
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
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OCTYLDODECANOL (UNII: 461N1O614Y)
CETYL PALMITATE (UNII: 5ZA2S6B08X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50090-2570-0	1 in 1 CARTON	10/28/2016
1		28.35 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	10/04/2004

Labeler - A-S Medication Solutions (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions		830016429	RELABEL(50090-2570)

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