FUNGAL NAIL TREATMENT MAXIMUM STRENGTH LIQUID- tolnaftate, undecylenic acid liquid

FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid by

Drug Labeling and Warnings

FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid by is a Otc medication manufactured, distributed, or labeled by Guangzhou Ruijiu Electronic Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

FUNGAL NAIL TREATMENT MAXIMUM STRENGTH LIQUID

ACTIVE INGREDIENT

TOLNAFTATE 1%
UNDECYLENIC ACID 25%

PURPOSE

Anti-fungal and Nail Renewal

INDICATIONS & USAGE

Antifungal use on fingernails, toenails, and the immediately adjacentskin.
·Prevents the recurrence of most athlete's foot with daily use.

·For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling.

WARNINGS

For external use only.

DO NOT USE

on children under 2 years of age unless directed by a doctor

WHEN USING

avoid contact with the eyes

STOP USE

Irritation occurs
There is no improvement within 4 weeks

KEEP OUT OF REACH OF CHILDREN

If accidental ingestion occurs, get medical help or contact a PoisonControl Center right away.

DOSAGE & ADMINISTRATION

Apply once daily, preferably at bedtime or at least eight hours before
washing. Clean and thoroughly dry the affected area, then use the
applicator brush provided to cover all affected nails. Ensure that the
application is evenly distributed across the entire nail plate.

STORAGE AND HANDLING

OTHER INFORMATIONSHAKE WELL BEFORE USEStore at room temperature 15°-30°C(59°- 86°F)
。Protect from freezing; if freezing occurs.warm to room temperatureKeep tightly closed when not in use

INACTIVE INGREDIENT

ALCOHOL
DIMETHICONE
C12-15 ALKYL LACTATE
ETHYLHEXYLGLYCERIN
TOCOPHEROL
SOPHORA FLAVESCENS ROOT
PHENOXYETHANOL
WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGAL NAIL TREATMENT MAXIMUM STRENGTH LIQUID 
tolnaftate, undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83767-003
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83767-003-01	6 in 1 PACKAGE	12/19/2024
1		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	12/19/2024

Labeler - Guangzhou Ruijiu Electronic Technology Co., Ltd. (631973699)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Ruijiu Electronic Technology Co., Ltd.		631973699	manufacture(83767-003)