Dr. Luke Fungal Nail Renewal by Dr.luke Healthcare LLC 83176-006 Completed

Dr. Luke Fungal Nail Renewal by

Drug Labeling and Warnings

Dr. Luke Fungal Nail Renewal by is a Otc medication manufactured, distributed, or labeled by Dr.luke Healthcare LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DR. LUKE FUNGAL NAIL RENEWAL- fungal nail renewal liquid 
Dr.luke Healthcare LLC

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83176-006 Completed

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal Disinfectant Treatment Solution

Use

For all caused by nail fungus
nail discoloration
nail thickening
nail splitting
nail crumbling

Warnings

For external use on nail
fungus(onychomycosis) only, pleasedon't use it on healthy nails
Don't use it on damaged skin,otherwise, your damaged skin maybe painful.
For people with severe skinulceration, please use it with caution.
Don't drink, avoid contact with your eye
Children use it under thesupervision of adults.
This product cannot replacemedicine.

Do not use

Do not use [OTC - DO NOT USE SECTION]
On damaged skin(cuts, abrasions, eczema, sunburn).
If you are allergic to any of the ingredients in this product.
If you are pregnant or breastfeeding.

WHEN USING SECTION

fungal infection itching

STOP USE section

You are allergic to vinegarsuch as itching, rash swelling of thelips, eyelids, and shortness ofbreath

ASK DOCTOR

You are allergic to vinegarsuch as itching, rash swelling of thelips, eyelids, and shortness ofbreath

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

Apply it in the day and night(twice a day).
Before using it for the first time.soak the diseased nail withwarm water to soften it, use thenail file to polish the nail, make itthin visibly, and scrape off thedirt on the nail (be careful not tohurt the nail bed), then apply the liquid.
After first use, every 2-3 daysuse the nail file to polish thesurface of the diseased nail andthen continue to use it.
lf swallowed, get medical helpor contact a poison controlcenter right away.

Inactive ingredients

Water, Acetic Acid, SophoraFlavescens，StelleraChamaejasme Linn., ChineseGolden Larch Bark, FructusCnidii, Crocus Sativus L, Ethanol

PRINCIPAL DISPLAY PANEL

83176-006-01

DR. LUKE FUNGAL NAIL RENEWAL 
fungal nail renewal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83176-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE)
CROCUS SATIVUS WHOLE (UNII: Z5C927G4XF)
WATER (UNII: 059QF0KO0R)
ACETIC ACID (UNII: Q40Q9N063P)
STELLERA CHAMAEJASME WHOLE (UNII: 80N0P0DD9J)
ALCOHOL (UNII: 3K9958V90M)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
CNIDIUM SEED (UNII: V1IA3S3CUS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83176-006-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	04/06/2023	11/21/2024

Labeler - Dr.luke Healthcare LLC (118868014)

Establishment
Name	Address	ID/FEI	Business Operations
Dr.luke Healthcare LLC		118868014	label(83176-006) , manufacture(83176-006)

Revised: 11/2024

Document Id: 276472ac-be62-d299-e063-6394a90a427e

34390-5

Set id: f8cc5335-fe24-7e63-e053-6294a90ad42a

Version: 2

Effective Time: 20241120