EXTRA STRENGTH TOENAIIL RENEWAL PEN- undecylenic acid, tolnaftate 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 and dry the affected nail and surrounding area.
Twist the pen base until the brush tip is saturated with essence.
Apply a thin layer to the entire nail, including the nail edges and underneath the nail crevices. Let it dy for 2-3 minutes.

Apply twice daily (morning and night) until a healthy nail has fully grown out.
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 ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks. If condition persists longer,
consult a doctor. This product is not effective on the scalp or nails.

INACTIVE INGREDIENT

DIMETHYL ISOSORBIDE
UREA
SALICYLIC ACID
MANUKA OIL
OREGANO LEAF OIL
TEA TREE OIL
CLOVE OIL
THYME OIL
ROSMARINUS OFFICINALIS (ROSEMARY) EXTRACT
CINNAMON OIL
KERATIN, TYPE I CYTOSKELETAL 18
BIOTIN
LEVOMENOL
CENTELLA ASIATICA WHOLE
TOCOPHEROL
MENTHOL
PROPANEDIOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH TOENAIIL RENEWAL PEN 
undecylenic acid, tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-010
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
THYME OIL (UNII: 2UK410MY6B)
CINNAMON OIL (UNII: E5GY4I6YCZ)
CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
KERATIN, TYPE I CYTOSKELETAL 18 (UNII: ZS6J3E8DAS)
CLOVE OIL (UNII: 578389D6D0)
BIOTIN (UNII: 6SO6U10H04)
LEVOMENOL (UNII: 24WE03BX2T)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PROPANEDIOL (UNII: 5965N8W85T)
ROSMARINUS OFFICINALIS (ROSEMARY) LEAF POWDER (UNII: IJ67X351P9)
TOCOPHEROL (UNII: R0ZB2556P8)
UREA (UNII: 8W8T17847W)
MANUKA OIL (UNII: M6QU9ZUH2X)
TEA TREE OIL (UNII: VIF565UC2G)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
MENTHOL (UNII: L7T10EIP3A)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-010-01	5 mL in 1 BOTTLE; 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(85966-010)