FUNGAL NAIL NIGHTTIME RENEWAL PATCHES- tolnaftate 1% patch

FUNGAL NAIL NIGHTTIME RENEWAL PATCHES by

Drug Labeling and Warnings

FUNGAL NAIL NIGHTTIME RENEWAL PATCHES by is a Otc medication manufactured, distributed, or labeled by 100 KARMA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Antifungal

DOSAGE & ADMINISTRATION

• Helps inhibit the growth of fungus.
• lmproves the appearance of nails affected by fungus,including discoloration,thickening, splitting, crumbing, and brittleness.

WARNINGS

For external use only

on children under 2 years ofage unless directed by a doctor on diaper rash

Avoid contact with eyes. do not exceed the recommended daly dosage unless directed by a doctor.

• mirritation occurs.
• there is no improvement within 4 weeks.

ask a health professional before use.

in case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

INDICATIONS & USAGE

▪ Clean & prepare the affected nail.
▪ Apply the antifungal solution to the affected nail.
▪ Apply the fungus nail patch. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips.
▪ Leave the patch on for 6–8 hours. Frequency: Use the patches consistently before bed.
▪ Maintain good foot hygiene.

OTHER SAFETY INFORMATION

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT

Water, Glycerin, Sodium Carboxymethy Cellulose, Butylene clycol, Urea

QUESTIONS

Email: service@treatonic.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGAL NAIL NIGHTTIME RENEWAL PATCHES 
tolnaftate 1% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85569-009
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
UREA (UNII: 8W8T17847W)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85569-009-01	32 in 1 PATCH; Type 0: Not a Combination Product	08/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/31/2025

Labeler - 100 KARMA INC (120186232)