SSPROTIP X EXTRA STRENGTH NAIL 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, irritation, 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.

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. For best results, gently file down thickened areas before application.

Peel off the protective film. Align the active gel center directly over the nail, ensuring full coverage of the surface and edges.

Press the pear-shaped base to the nail root, wrap the tapered top over the fingertip, and hold firmly for 10s.

Keep the patch on for 24 hours. Replace it once a day (increase frequency for severe cases). Clean the nail thoroughly between replacing.

The patch is water-resistant for showers. Avoid soaking for over 30 minutes. Use a waterproof cover if swimming or bathing.

Use consistently until the damaged nail is fully replaced by healthy, clear growth. Full restoration may take several months.

This product is not effective on the scalp or nails.

INACTIVE INGREDIENT

UREA
WATER
LEVOMENOL
TEA TREE OIL
OREGANO LEAF OIL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SSPROTIP X EXTRA STRENGTH NAIL RENEWAL PATCHES 
tolnaftate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-016
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
UREA (UNII: 8W8T17847W)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
TEA TREE OIL (UNII: VIF565UC2G)
LEVOMENOL (UNII: 24WE03BX2T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-016-01	38 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(85966-016)