TOLNAFTATE CREAM 1%- tolnaftate cream

Tolnaftate Cream 1% by

Drug Labeling and Warnings

Tolnaftate Cream 1% by is a Otc medication manufactured, distributed, or labeled by Pharmacy Value Alliance, LLC., Trifecta Pharmaceuticals USA, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Anti-Fungal

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

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

For External Use Only

When using this product avoid contact with the eyes

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

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

Stop use and ask a doctor if

• irritation occurs
• there is no improvement within 4 weeks

Other Information

• Store between 20° to 25°C (68° to 77°F)
• Lot No & Expiration Date: See box or crimp of tube

Inactive ingredients:

Cetyl alcohol, Ethylparabe, Glycerol, Glyceryl Monostearate, Mineral Oil, Petrolatum, Purified Water, Sodium Dodecyl sulfate

Soothes Itching, Burning and Cracking

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087 USA

www.emersongroup.com

Packaging

INGREDIENTS AND APPEARANCE

TOLNAFTATE CREAM 1% 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-152
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
WATER (UNII: 059QF0KO0R)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-152-01	1 in 1 BOX	08/31/2016
1		28 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	08/23/2016

Labeler - Pharmacy Value Alliance, LLC. (101668460)

Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)