MAJOR CLOTRIMAZOLE- clotrimazole cream

Major Clotrimazole by

Drug Labeling and Warnings

Major Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Central Texas Community Health Centers. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Principal Display Panel - 15 g Tube Label

CommUnityCare Federally Qualified Health Centers

Clotrimazole
1%
TOPICAL
Cream

Date:

Name:
Dr.

USE AS DIRECTED.

123456

1/1/01

Clotrimazole 1% TOPICAL Cream 15g NDC: 76413-304-15

Batch: 123456
Lot: 123456
Exp: 1/1/01
MAJOR

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

INGREDIENTS AND APPEARANCE

MAJOR CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76413-304(NDC:0904-7822)
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76413-304-15	1 in 1 CARTON
1		14.17 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/04/2004

Labeler - Central Texas Community Health Centers (079674019)

Establishment
Name	Address	ID/FEI	Business Operations
Central Texas Community Health Centers		079674019	REPACK(76413-304) , RELABEL(76413-304)