SUNMARK ANTIFUNGAL- tolnaftate cream

sunmark by

Drug Labeling and Warnings

sunmark by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• helps prevent most athlete's foot from recurring when used daily
• effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking

Warnings

For external use only

When using this product 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 within 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

• wash affected area and dry thoroughly
• apply a thin layer over affected area twice daily (morning and night)
• supervise children in the use of this product
• this product is not effective on scalp or nails

For athlete's foot

• pay special attention to spaces between toes
• wear well-fitting shoes, 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 condition persists longer, consult a doctor

Other information

• Store between 15° - 30°C (59° - 86°F)
• See end panel of carton and tube crimp for lot number and expiration date

Inactive ingredients

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

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Distributed by McKesson
One Post Street
San Francisco, CA 94104

HOW SUPPLIED

Product: 50090-3358

NDC: 50090-3358-0 15 g in a TUBE / 1 in a CARTON

Tolnaftate

INGREDIENTS AND APPEARANCE

SUNMARK   ANTIFUNGAL
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-3358(NDC:49348-155)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Polyethylene Glycol 3350 (UNII: G2M7P15E5P)
titanium dioxide (UNII: 15FIX9V2JP)
petrolatum (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50090-3358-0	1 in 1 CARTON	02/01/2018
1		15 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	02/17/2006

Labeler - A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Business Operations
A-S Medication Solutions		830016429	RELABEL(50090-3358)