NAIL FUNGUS TREATMENT PEN- undecylenic acid, tolnaftate liquid

Nail Fungus Treatment Pen by

Drug Labeling and Warnings

Nail Fungus Treatment Pen by is a Otc medication manufactured, distributed, or labeled by GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD, Guangzhou Meixi Biotechnology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

UNDECYLENIC ACID 25%
TOLNAFTATE 1%

PURPOSE

Antifungal

INDICATIONS & USAGE

For the effective treatment of nail fungus, discoloration, thickening,splitting, crumbling and brittleness.
Provides effective relief from itching, scaling, burning, redness, sorenessand irritation while curing most athlete's foot (tinea pedis) and jock itch(tinea cruris).
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. lf 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 base of the pen clockwise until the brush tip is saturated.
Apply a thin layer to the entire nail. Let it dry for 2-3 minutes.
Apply twice daily (morning and night) until a healthy nail has fully grown out.
For athletes 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..This product is not effective on the scalp or nails. lf condition persistslonger, consult a doctor.

INACTIVE INGREDIENT

MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
OREGANO OIL
CEYLON CINNAMON BARK OIL
LAVANDULA ANGUSTIFOLIA (LAVENDER) EXTRACT
CAPRYLIC/CAPRIC DIGLYCEROL SUCCINATE
ISOPROPYL MYRISTATE
TOCOPHEROL
BISABOLOL
PANTHENOL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAIL FUNGUS TREATMENT PEN 
undecylenic acid, tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85966-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
BISABOLOL (UNII: 24WE03BX2T)
CINNAMON BARK OIL (UNII: XE54U569EC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
TOCOPHEROL (UNII: R0ZB2556P8)
CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE (UNII: J4BY50FL78)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PANTHENOL (UNII: WV9CM0O67Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85966-005-01	3 in 1 BOX	09/29/2025
1		5 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	09/29/2025

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

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Meixi Biotechnology Co., Ltd.		625724571	manufacture(85966-005)