TOLCYLEN ANTIFUNGAL SOLUTION- tolnaftate solution

Tolcylen Antifungal Solution by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Warnings

Keep out of reach of children

Uses

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

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.

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 and the areas around the edges and under the front of the nails.
■ 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.
■ Wash hands after each use. Store and use at room temperature.

Inactive Ingredeints

Inactive Ingredients: Ethyl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Propylene Glycol, Water
Cosmetic Ingredients: Urea, Lactic Acid, Jojoba Oil, Undecylenic Acid, Dimethyl Isosorbide, Vitamin E

Outer Carton - Principal Display Panel

INGREDIENTS AND APPEARANCE

TOLCYLEN ANTIFUNGAL SOLUTION 
tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70945-100
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LACTIC ACID (UNII: 33X04XA5AT)
ETHYL ACETATE (UNII: 76845O8NMZ)
UREA (UNII: 8W8T17847W)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
JOJOBA OIL (UNII: 724GKU717M)

Product Characteristics
Color	yellow (Clear Fluid)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70945-100-75	1 in 1 CARTON	12/16/2016
1		7.5 mL in 1 TUBE, WITH APPLICATOR; Number of Units = 1; 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(70945-100)