TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH LIQUID- tolnaftate liquid

TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid by

Drug Labeling and Warnings

TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid by is a Otc medication manufactured, distributed, or labeled by Shenzhen Ctrip Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Anti-fungal and Nail Renewal

INDICATIONS & USAGE

Antifungal use on fingemails, toenails, and the immediately adjacent skin.
Fungal nails, Athlete's Foot, Tinea Manuum, Ringwomcaused byfungus and bacterial infection.
For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling

WARNINGS

Keep away from fire and flame.
Keep out of reach of children.
For use on nails and the immediately adjacent skin only.

DO NOT USE

If a reaction suggesting sensitivity or iritation occurs.

WHEN USING

Not for ophthalmic, oral, or intravaginal use

STOP USE

lf the area of application shows signs of increased iritation.
There is no improvement within 8 weeks.
When Pregnant or breast-feeding

KEEP OUT OF REACH OF CHILDREN

If accidental ingestion occurs, seek medical assistance or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Use once daily, preferably before bedtimeUnscrew the cap and tilt the bottle to apply the medicine directly to thenail. The medication will then penetrate deeply into the nail.If the nail area is infected, spray the medication onto the affected toearea.

STORAGE AND HANDLING

SHAKE WELL BEFORE USE
Store at room temperature 5--30°C(41°-86°F), Please store in a cool,dry place away from direct sunlight.
Keep tightly closed when not in use

INACTIVE INGREDIENT

UNDECYLENIC ACID
ALCOHOL
DIMETHICONE
C12-15 ALKYL LACTATE
ETHYLHEXYLGLYCERIN
TOCOPHEROL
EDETATE DISODIUM
PHENOXYETHANOL
WATER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH LIQUID 
tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84614-002
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

Inactive Ingredients
Ingredient Name	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
TOCOPHEROL (UNII: R0ZB2556P8)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIMETHICONE (UNII: 92RU3N3Y1O)
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84614-002-01	2 in 1 PACKAGE	08/23/2024
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	08/23/2024

Labeler - Shenzhen Ctrip Technology Co., Ltd. (403113060)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Ctrip Technology Co., Ltd.		403113060	manufacture(84614-002)