EXTRA STRENGTH TOENAIL RENEWAL SOLUTION- undecylenic acid, tolnaftate solution

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Undecylenic Acid 25%
Tolnaftate 1%

PURPOSE

Antifungal

INDICATIONS & USAGE

Helps improve the appearance of nails and supports the renewal of discolored or rough nal surfaces through mechanical and chemical exfoliating action.

Proven clinically effective in the treatment of most athletes foot (tinea pedis). jockich (tinea cruris), and ringworm (tinea corporis)
Relieves itching. scaling. cracking. burning, and discomfort associated with these conditions

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 nal and dy thoroughly Fie the nallsurface to remove thickness After each use, wrap the nail file in a tissue and discard it (for single use only)
Use a dropper to apply and a cotton swab to spread evenly. If using a brush, replace it regularly
Apply a thin layer of the product over affected area twice daly morning and night Wait 2-3 minutes for the treamentto be fully absorbed.
Allow to dny.then wrap the afected toe with the antfungal bandage.For best resuts use overnight or before wearing shoestokeep the medication in place The bandage is self-adhesive.
TIPS:
For athlete's foot Pay special attention to spaces between the toes wear well-ftting ventilated shoes and change shoes and socks at least once daily
For athlete's foot and jock ich. use daily for a full4-week course Ifsymptoms persist. consut a doctor Not intended for use on the scalp or nails
This product is not effective on the scalp or nails.

INACTIVE INGREDIENT

Urea
Ethoxydiglycol
Lactic Acid
Melaleuca Ericifolia Leaf Oil
Eucalyptus Globulus Leaf Oil
Leptospermum Scoparium Branch/Leaf Oil
Origanum Vulgare Leaf Oil
Eugenia Caryophyllus (Clove) Bud Oil
Salicylic Acid
Simmondsia Chinensis Seed Oil
Tocopheryl Acetate
Biotin
Glycerin
Aqua

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH TOENAIL RENEWAL SOLUTION 
undecylenic acid, tolnaftate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-013
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
LEPTOSPERMUM SCOPARIUM BRANCH/LEAF OIL (UNII: M6QU9ZUH2X)
UREA (UNII: 8W8T17847W)
BIOTIN (UNII: 6SO6U10H04)
GLYCERIN (UNII: PDC6A3C0OX)
AQUA (UNII: 059QF0KO0R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
EUCALYPTUS GLOBULUS LEAF OIL (UNII: 2R04ONI662)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
LACTIC ACID (UNII: 33X04XA5AT)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ORIGANUM VULGARE LEAF OIL (UNII: 7D0CGR40U1)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
EUGENIA CARYOPHYLLUS (CLOVE) BUD OIL (UNII: 578389D6D0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-013-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/08/2026
2	NDC: 85966-013-02	5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/08/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	04/08/2026

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Meixi Biotechnology Co., Ltd.		625724571	manufacture(85966-013)