TINACTIN- tolnaftate cream

Tinactin by

Drug Labeling and Warnings

Tinactin by is a Otc medication manufactured, distributed, or labeled by Delpharm Montreal Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)
• helps prevent most athlete's foot with daily use
• for effective relief of 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

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
• 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
• use daily for 4 weeks; if condition persists longer, ask a doctor
• to prevent athlete's foot, apply once or twice daily (morning and/or night)
• this product is not effective on the scalp or nails

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic, white petrolatum

Questions?

1-866-360-3266

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Distributed by Bayer HealthCare LLC Whippany, NJ 07981

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Tinactin ®

ANTIFUNGAL

tolnaftate

CREAM

Relieves:

• itching
• burning

NET WT

30g (1 oz)

INGREDIENTS AND APPEARANCE

TINACTIN 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69213-1190
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
CETETH-20 (UNII: I835H2IHHX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
PETROLATUM (UNII: 4T6H12BN9U)

Product Characteristics
Color	white (White to Off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69213-1190-1	1 in 1 CARTON	09/23/1993
1		15 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69213-1190-2	1 in 1 CARTON	09/23/1993
2		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	09/23/1993

Labeler - Famar Montreal Inc (203565379)