Major Clotrimazole (Clotrimazole) Cream [Remedyrepack Inc.] -

MAJOR CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [REMEDYREPACK INC.]
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NDC	70518-0207-0
Set ID	69c2016e-516a-4852-9f41-64a59c3586ff
Category	HUMAN OTC DRUG LABEL
Packager	REMEDYREPACK INC.
Generic Name
Product Class	Azole Antifungal
Product Number
Application Number	PART333C

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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

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
PRINCIPAL DISPLAY PANEL
DRUG: Major Clotrimazole

GENERIC: CLOTRIMAZOLE

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0207-0

PACKAGING: 14.17 g in 1 TUBE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):
- CLOTRIMAZOLE 10mg in 1g
INACTIVE INGREDIENT(S):
- WATER
- CETOSTEARYL ALCOHOL
- POLYSORBATE 60
- BENZYL ALCOHOL
- SORBITAN MONOSTEARATE
- .ALPHA.-TOCOPHEROL ACETATE
- ALOE VERA LEAF
- OCTYLDODECANOL
- CETYL PALMITATE

INGREDIENTS AND APPEARANCE

MAJOR CLOTRIMAZOLE
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70518-0207(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:70518-0207-0	1 in 1 CARTON	02/28/2017
1		14.17 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	02/28/2017

Labeler - REMEDYREPACK INC. (829572556)

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Medic

MAJOR CLOTRIMAZOLE (CLOTRIMAZOLE) CREAM [REMEDYREPACK INC.]

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