EXTRA STRENGTH TOENAIL RENEWAL PEN- undecylenic acid, tolnaftate liquid

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 nail surfaces through
mechanical and chemical exfoliating action.
Proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (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.
Use twice daily until a healthy new nail has fully grown Trim and file nails to support maximum absorption.

The elastic bandage should not be wrapped too tightly. Change daily.

The nail file is for single-person use. Do not share or reuse

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
Pro Tip: To prevent re-infection, always disinfect the file with 70% rubbing alcohol after each use.
Twist the base of the pen clockwise until the liquid flows to the nib.
Apply a thin layer of the product over affected area twice daily (morning and night. Wait 2-3 minutes for the treatment to be fully absorbed.

Allow to dry, then apply the affected toe with the waterproof protective film. For best results, use overnight or
before wearing shoes to keep the medication in place.
NOTE:
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 a full 4-week course. If symptoms persist, consult 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
Dimethyl Sulfone
Biotin
Melaleuca Ericifolia Leaf Oil
Leptospermum Scoparium Branch/Leaf Oil
Eucalyptus Globulus Leaf Oil
Origanum Vulgare Leaf Oil
Eugenia Caryophyllus (Clove) Bud Oil
Squalane
Simmondsia Chinensis Seed Oil
Salicylic Acid
Tocopheryl Acetate
Ethylhexylglycerin
Aqua

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH TOENAIL RENEWAL PEN 
undecylenic acid, tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-012
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
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LACTIC ACID (UNII: 33X04XA5AT)
ORIGANUM VULGARE LEAF OIL (UNII: 7D0CGR40U1)
EUGENIA CARYOPHYLLUS (CLOVE) BUD OIL (UNII: 578389D6D0)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
AQUA (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SALICYLIC ACID (UNII: O414PZ4LPZ)
BIOTIN (UNII: 6SO6U10H04)
LEPTOSPERMUM SCOPARIUM BRANCH/LEAF OIL (UNII: M6QU9ZUH2X)
SQUALANE (UNII: GW89575KF9)
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL (UNII: 724GKU717M)
UREA (UNII: 8W8T17847W)
EUCALYPTUS GLOBULUS LEAF OIL (UNII: 2R04ONI662)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-012-01	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(85966-012)