83179-007-01 Dr. Luke Nail Repair Pen

Dr. Luke Nail Repair Pen by

Drug Labeling and Warnings

Dr. Luke Nail Repair Pen 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 NAIL REPAIR PEN- nail repair pen 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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83179-007-01
Dr. Luke Nail Repair Pen

Active Ingredient

Undecylenic Acid 10%

Purpose

Antifungal

Use

Improving nail appearance
Antifungal of Candida albicans or other fungi
According to proven tests, the disinfecting time of the product on Candidaalbicans is 2 minutes and the average antibacterial rate is 100%

Warnings

For external use on nailfungus(onychomycosis) only, pleasedon't use it on healthy nails
Don't use it on damaged skin,otherwise, your damaged skin maybe painful.
Avoid contact with your eye. This product cannot replace medicine.

Do not use

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

Improving nail appearance
Antifungal of Candida albicans or other fungi
According to proven tests, the disinfecting time of the product on Candidaalbicans is 2 minutes and the average antibacterial rate is 100%

STOP USE section

You are allergic to this product (such as itching, rash swelling of the lips.evelids, and shortness of breath)

ASK DOCTOR

You are allergic to this product (such as itching, rash swelling of the lips.evelids, and shortness of breath)

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Directions

1.Wash and dry nails before application. Remove the cap covering thebrush on the pen.
2.Twist the end of the pen clockwise to dispense liquid onto the brush.
3.Using the brush, apply a thin layer of liquid onto the affected area.
4.Let the area dry, then reapply another thin layer. Do this two more times.
5.Repeat this process 3 times daily for 6-8 weeks(or) until the infection is gone.

Inactive ingredients

Deacetylation Chitin, Salicylic Acid, And Angelica Dahurica

QUESTIONS

www.drlukehealthcare.com
info@drlukehealthcare.com

PRINCIPAL DISPLAY PANEL

83176-007-01

DR. LUKE NAIL REPAIR PEN 
nail repair pen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83176-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	10 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CHITIN (UNII: 8SH93A7QWW)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
SALICYLIC ACID (UNII: O414PZ4LPZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83176-007-01	3 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2023	04/18/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M005	04/06/2023	04/18/2023

Labeler - Dr.luke Healthcare LLC (118868014)

Establishment
Name	Address	ID/FEI	Business Operations
Dr.luke Healthcare LLC		118868014	label(83176-007) , manufacture(83176-007)

Revised: 4/2023

Document Id: f99cf230-b18d-62d6-e053-6294a90a68ea

34390-5

Set id: f8cd4373-2203-5773-e053-6294a90ae369

Version: 2

Effective Time: 20230418