Tolcylen Antifungal Solution (solution) Marlinz Pharma, LLC (2024)

Dosage form: solution
Ingredients: TOLNAFTATE 1mg in 100mL
Labeler: Marlinz Pharma, LLC
NDC code: 70945-100

Medically reviewed by Drugs.com. Last updated on Jun 2, 2023.

Active Ingredient

Tolnaftate 1%

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

Tolcylen Antifungal Solution (solution) Marlinz Pharma, LLC (1)Tolcylen Antifungal Solution (solution) Marlinz Pharma, LLC (2)Tolcylen Antifungal Solution (solution) Marlinz Pharma, LLC (3)Tolcylen Antifungal Solution (solution) Marlinz Pharma, LLC (4)

TOLCYLEN ANTIFUNGAL SOLUTION
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70945-100
Route of AdministrationTOPICALDEA Schedule
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1mg in100mL
Inactive Ingredients
Ingredient NameStrength
DIMETHYL ISOSORBIDE
ISOPROPYL ALCOHOL
ISOPROPYL MYRISTATE
LACTIC ACID
ETHYL ACETATE
UREA
UNDECYLENIC ACID
PROPYLENE GLYCOL
JOJOBA OIL
Product Characteristics
Coloryellow (Clear Fluid) Score
ShapeSize
FlavorImprint Code
Contains
Packaging
#Item CodePackage Description
1NDC:70945-100-751 TUBE, WITH APPLICATOR in 1 CARTON
17.5 mL in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/16/2016

Labeler -Marlinz Pharma, LLC(080251509)

Establishment
NameAddressID/FEIOperations
Marlinz Pharma, LLC080251509manufacture(70945-100)

Document Id: 0bb9ed06-551f-4d53-9100-4a9755cac059

Set id: a0ae6ab7-960d-4fed-ab31-fb70882fc7e0

Version: 2

Effective Time: 20170612

Marlinz Pharma, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circ*mstances.

Medical Disclaimer

Tolcylen Antifungal Solution (solution) Marlinz Pharma, LLC (2024)
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