Tolcylen Antifungal Cream by Marlinz Pharma, LLC

Tolcylen Antifungal Cream by

Drug Labeling and Warnings

Tolcylen Antifungal Cream by is a Otc medication manufactured, distributed, or labeled by Marlinz Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOLCYLEN ANTIFUNGAL CREAM- tolnaftate cream 
Marlinz Pharma, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Tolnaftate

Warnings

Keep out of reach of children

Purpose

Antifungal

Warnings

Warnings ■ Do not use on children under 2 years of age ■ For external use only ■ Avoid contact with the eyes. If eye contact occurs, wash thoroughly with water ■ Stop use and consult
a physician if irritation occurs or if there is no improvement within four (4) weeks ■ Keep out of reach of children ■ If swallowed, get medical help or contact a poison control center right
away ■ If pregnant or breast-feeding, ask a health-care professional before use.

Inactive Ingredients

Purified Water, Undecylenic Acid, White Petrolatum, Urea, Lactic Acid, Tea Tree Oil, Sorbitol Solution, Cetearyl Alcohol, Propylene Glycol,
Ceteareth-20, Simethicone, Glyceryl & Polyethylene Glycol Monostearate, Sorbic Acid.

Directions

Wash the affected area with soap and water ■ Dry thoroughly, then apply a thin layer over the affected area ■ Use twice daily (morning and night) or as
directed by a physician ■ Pay special attention to the spaces between the toes ■ Wear well-fitted ventilated shoes and change socks at least once daily ■ Use daily for
four (4) weeks. If condition persists longer, consult a physician ■ This product is not effective on the scalp or nails ■ Wash hands after each use.
Store and use at room temperature.

Uses

Cures most Athlete’s Foot (Tinea Pedis) ■ Relieves itching, cracking, burning and scaling, which accompanies this condition ■ Prevents recurrence of Athlete’s
Foot

Principle Display Panel - Outer Carton

TOLCYLEN ANTIFUNGAL CREAM 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70945-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	.2 mg  in 20 mg

Inactive Ingredients
Ingredient Name	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N)
TEA TREE OIL (UNII: VIF565UC2G)
UREA (UNII: 8W8T17847W)
LACTIC ACID (UNII: 33X04XA5AT)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
SORBITOL (UNII: 506T60A25R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
SORBIC ACID (UNII: X045WJ989B)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70945-200-20	1 in 1 PACKAGE	12/16/2016
1		20 mg in 1 TUBE, WITH APPLICATOR; 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	12/16/2016

Labeler - Marlinz Pharma, LLC (080251509)

Establishment
Name	Address	ID/FEI	Business Operations
Marlinz Pharma, LLC		080251509	manufacture(70945-200)

Revised: 12/2016

Document Id: f9ee4b99-50d1-41a5-9a98-7981c45325e3

34390-5

Set id: cbd748d6-0348-4d51-8bcd-843602a2ed7f

Version: 2

Effective Time: 20161216

 

Marlinz Pharma, LLC