SSPROTIP X EXTRA STRENGTH TOENAIL RENEWAL SOLUTION- tolnaftate,undecylenic acid liquid

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

UNDECYLENIC ACID (25%)
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 the affected nail and dry thoroughly. File the nail surface to remove thickness. Clean the nail file after each use.
Using a disposable cotton swab or dropper to apply.
Apply a thin layer of the solution over affected area twice daily (morning and night). Supervise children in the use of this product.
Wait 2-3 minutes for the solution to be fully absorbed.
For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
For athlete's foot and jock itch, use daily for 4 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

INACTIVE INGREDIENT

UREA
ETHOXYDIGLYCOL
DIMETHYL SULFONE
LACTIC ACID
MANUKA OIL
CLOVE BUD OIL
EUCALYPTUS GLOBULUS LEAF OIL
TEA TREE OIL
OREGANO OIL
SALICYLIC ACID
SQUALANE
SIMMONDSIA CHINENSIS
BIOTIN
TOCOPHERYL ACETATE
AQUA
ETHYLHEXYLGLYCERIN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SSPROTIP X EXTRA STRENGTH TOENAIL RENEWAL SOLUTION 
tolnaftate,undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	0.01 g  in 1 mL
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	0.25 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SQUALANE (UNII: GW89575KF9)
SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95)
TEA TREE OIL (UNII: VIF565UC2G)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
EUCALYPTUS GLOBULUS OIL (UNII: 2R04ONI662)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
BIOTIN (UNII: 6SO6U10H04)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AQUA (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
UREA (UNII: 8W8T17847W)
SALICYLIC ACID (UNII: O414PZ4LPZ)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
MANUKA OIL (UNII: M6QU9ZUH2X)
LACTIC ACID (UNII: 33X04XA5AT)
CLOVE OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-017-01	1 in 1 BOX	05/22/2026
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 85966-017-02	2 in 1 BOX	05/22/2026
2		30 mL in 1 BOTTLE; 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	05/22/2026

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Meixi Biotechnology Co., Ltd.		625724571	manufacture(85966-017)