FUNGIFREE FUNGAL NAIL PATCHES- tolnaftate patch

FungiFree Fungal Nail Patches by

Drug Labeling and Warnings

FungiFree Fungal Nail Patches by is a Otc medication manufactured, distributed, or labeled by YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions

- Remove any nail polish before use. Clean and thoroughly dry the affected area. - Peel off the protective film from the patch, starting with the outer edge and then the inner side. - Center the white area of the patch over the infected part of the nail. - Apply the adhesive side directly onto the nail. - Wrap the sides of the patch around the toe or finger to ensure a snug fit. - Fold the remaining adhesive part over the toe or fingertip. - Leave the patch on for 6-8 hours. For best results, use overnight for 3-6 months

OTHER SAFETY INFORMATION

Other information Store at room temperature 15°-30°C (59°-86°F), away from excess heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients Glycerin, Tartaric Acid, Polysorbate 80, 1.2-Hexanediol, Disodium EDTA, Cellulose Gum, Sodium Polyacrylate, Aluminum Glycinate, Fumaric Acid, Butylene Glycol, Urea, Water

PRINCIPAL DISPLAY PANEL

Drug Facts

Active ingredients

Tolnaftate 1.0%

Anti-fungal

Repairs fungal nail damage and improves nail appearance

Do not use on children under 3 years of age unless directed by a doctor.

When using this product avoid contact with eyes. In case of contact, rinse thoroughly with water

Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away

Warnings

For external use only

INGREDIENTS AND APPEARANCE

FUNGIFREE FUNGAL NAIL PATCHES 
tolnaftate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83364-013
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 g

Inactive Ingredients
Ingredient Name	Strength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALUMINUM GLYCINATE (UNII: 1K713C615K)
CELLULOSE GUM (UNII: K679OBS311)
TARTARIC ACID (UNII: W4888I119H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
UREA (UNII: 8W8T17847W)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
FUMARIC ACID (UNII: 88XHZ13131)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83364-013-01	21 in 1 PATCH	10/21/2024
1		0.7 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/21/2024

Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)