TOLCYLEN ANTIFUNGAL SOLUTION- tolnaftate solution 
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 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

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TOLCYLEN ANTIFUNGAL SOLUTION 
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70945-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
Coloryellow (Clear Fluid) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70945-100-751 in 1 CARTON12/16/2016
17.5 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/16/2016
Labeler - Marlinz Pharma, LLC (080251509)

Revised: 2/2022
Document Id: d6f9dc73-a54c-66eb-e053-2995a90a9a89
Set id: a0ae6ab7-960d-4fed-ab31-fb70882fc7e0
Version: 4
Effective Time: 20220201
 
Marlinz Pharma, LLC