TOLNAFTATE CREAM 1% ANTIFUNGAL- tolnaftate cream

Tolnaftate Cream 1% ANTIFUNGAL by

Drug Labeling and Warnings

Tolnaftate Cream 1% ANTIFUNGAL by is a Otc medication manufactured, distributed, or labeled by Trifecta Pharmaceuticals Usa Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Anti-Fungal

KEEP OUT OF REACH OF CHILDREN

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

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 healthcare professional if ● irritation occurs ● there is no improvement within 4 weeks improvement 

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

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 conditions persists longer, ask a healthcare professional.

● to prevent athlete's foot, apply once or twice daily (morning and/or night)

● this product is not effective on the scalp or nails.

Inactive ingredients

Cetostearyl alcohol, ethylparaben, glycerol, light mineral oil, monostearin, petrolatum, purified water, sodium dodecyl sulfate

Other information

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

SPL UNCLASSIFIED SECTION

100% GUARANTEED

Cures and Prevents Most Athlete's Foot

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC

www.trifecta-pharma.com

Packaging

INGREDIENTS AND APPEARANCE

TOLNAFTATE CREAM 1% ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69396-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERIN (UNII: PDC6A3C0OX)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69396-016-20	1 in 1 BOX	04/09/2016
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69396-016-05	1 in 1 BOX	04/09/2016
2		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	04/09/2016

Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)