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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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83176-006
Dr. Luke Fungal Nail Renewal

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

83176-006-01

DR. LUKE FUNGAL NAIL RENEWAL 
fungal nail renewal liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83176-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83176-006-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00504/06/2023
Labeler - Dr.luke Healthcare LLC (118868014)
Establishment
NameAddressID/FEIBusiness Operations
Dr.luke Healthcare LLC118868014label(83176-006) , manufacture(83176-006)

Revised: 4/2023
Document Id: f8cc5335-fe25-7e63-e053-6294a90ad42a
Set id: f8cc5335-fe24-7e63-e053-6294a90ad42a
Version: 1
Effective Time: 20230408
 
Dr.luke Healthcare LLC