SUNMARK CLOTRIMAZOLE- clotrimazole cream

SUNMARK CLOTRIMAZOLE by

Drug Labeling and Warnings

SUNMARK CLOTRIMAZOLE by is a Otc medication manufactured, distributed, or labeled by McKesson. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole USP, 1%

Purpose

Antifungal

Uses

• cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• effectively relieves itching, cracking, burning and discomfort which can accompany these conditions

Warnings

For external use only

When using this product

• use only as directed
• avoid contact with the eyes

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch)

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• for best results, follow directions and continue treatment for length of time indicated
• to open, use pointed end on cap to puncture seal
• clean skin with soap and water and dry thoroughly
• apply a thin layer over affected area morning and evening
• for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• best results in athlete's foot and ringworm are usually obtained with 4 weeks use, and in jock itch, with 2 weeks use. If satisfactory results have not occurred within these times, ask a doctor or pharmacist.
• children under 12 years of age should be supervised in the use of this product
• this product is not effective on the scalp or nails

Other information

• store between 2°-30°C (36°-86°F)
• do not use if seal on tube is broken or is not visible
• See box 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

SPL UNCLASSIFIED SECTION

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

sunmark™

antifungal cream

Clotrimazole Cream USP, 1%

CURES MOST ATHLETE'S FOOT

NET WT 1 OZ (30 g)

INGREDIENTS AND APPEARANCE

SUNMARK CLOTRIMAZOLE 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-279
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
benzyl alcohol (UNII: LKG8494WBH)
cetostearyl alcohol (UNII: 2DMT128M1S)
cetyl esters wax (UNII: D072FFP9GU)
octyldodecanol (UNII: 461N1O614Y)
polysorbate 60 (UNII: CAL22UVI4M)
water (UNII: 059QF0KO0R)
sorbitan monostearate (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-279-72	1 in 1 CARTON	08/31/1993
1		30 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	08/31/1993

Labeler - Strategic Sourcing Services LLC (116956644)