EXTRA STRENGTH TOENAIIL RENEWAL SOLUTION- 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 athletes 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

Wash the affected area 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 product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product.
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

UREA
DIETHYLENE GLYCOL MONOETHYL ETHER
ALOE VERA LEAF
SALICYLIC ACID
TEA TREE OIL
OREGANO LEAF OIL
MANUKA OIL
ALLSPICE LEAF OIL
THYMUS VULGARIS (THYME) LEAF EXTRACT
BIOTIN
MENTHOL
JEEN VITAMIN E JEEN
LEVOMENOL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH TOENAIIL RENEWAL SOLUTION 
undecylenic acid, tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-011
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
MANUKA OIL (UNII: M6QU9ZUH2X)
SALICYLIC ACID (UNII: O414PZ4LPZ)
TEA TREE OIL (UNII: VIF565UC2G)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
UREA (UNII: 8W8T17847W)
PIMENTA LEAF OIL (UNII: 60T6W3867P)
LEVOMENOL (UNII: 24WE03BX2T)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
THYMUS VULGARIS (THYME) LEAF (UNII: GRX3499643)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BIOTIN (UNII: 6SO6U10H04)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-011-01	1 in 1 BOX	04/08/2026
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 85966-011-02	2 in 1 BOX	04/08/2026
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	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(85966-011)