SAVILAND PRO EXTRA STRENGTH TOENAIL RENEWAL PATCHES- tolnaftate patch

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

TOLNAFTATE(1%)

PURPOSE

Antifungal

INDICATIONS & USAGE

For effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis).
For effective relief of itching, scaling, cracking, burning, redness, soreness, iritation, discomfort and chafing associated with jock itch.
Proven effective in the prevention of most athlete's foot (tinea pedis) with daily use.

WARNINGS

For external use only. Store in a cool place and avoid sunshine and heat.

DO NOT USE

Do not use . on children under 2 years of age unless directed by a doctor.

WHEN USING

When using this product avoid contact with the eyes or damaged skin.
It's normal to feel a slight, temporary sensation of irritation, tingling, or burning. If symptoms persist or worsen, discontinue use.

STOP USE

Stop use and ask a doctor if · irritation occurs or if there is no improvement within 4 weeks

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Clean and dry the affected nail and surrounding area.
Remove the patch from its protective film.
Place it directly onto the infected nail, ensuring full coverage.
Gently press down on the edges of the patch to make sure it is firmly adhered to the nail and skin, with no air bubbles
Keep the patch on for 24 hours. Replace it once a day, preferably after showering.
This product is not effective on the scalp or nails.

INACTIVE INGREDIENT

UREA
LACTIC ACID
MENTHYL ALCOHOL
TERPINEN-4-OL
OREGANO LEAF OIL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SAVILAND PRO EXTRA STRENGTH TOENAIL RENEWAL PATCHES 
tolnaftate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	0.01 g

Inactive Ingredients
Ingredient Name	Strength
MENTHOL (UNII: L7T10EIP3A)
4-TERPINEOL (UNII: L65MV77ZG6)
UREA (UNII: 8W8T17847W)
LACTIC ACID (UNII: 33X04XA5AT)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-014-01	35 in 1 BOX	05/21/2026
1		1 in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/21/2026

Labeler - GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD (847858432)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Meixi Biotechnology Co., Ltd.		625724571	manufacture(85966-014)