DR. LUKE FUNGAL NAIL RENEWAL- fungal nail renewal liquid

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 DANOUS LAND FLOOW LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tolnaftate 1%

PURPOSE

Antifungal Disinfectant Treatment Solution

INDICATIONS & USAGE

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

• 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

fungal infection itching

STOP USE

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

ASK DOCTOR/PHARMACIST

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.

INSTRUCTIONS FOR USE

• 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 INGREDIENT

Water, Acetic Acid, SophoraFlavescens，Stellera Chamaejasme whole, ChineseGolden Larch Bark, FructusCnidii, Crocus Sativus Whole, Ethanol,Cnidium Seed, Alcohol

OTHER SAFETY INFORMATION

• Do not use if glued carton end flaps are open or if the tube seal is broken.
• Store at 68°-77°F (20°-25C).
• Keep container tightly closed

DOSAGE & ADMINISTRATION

Apply it in the day and night (twice a day)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. LUKE FUNGAL NAIL RENEWAL 
fungal nail renewal liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87147-005
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
WATER (UNII: 059QF0KO0R)
ACETIC ACID (UNII: Q40Q9N063P)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
STELLERA CHAMAEJASME WHOLE (UNII: 80N0P0DD9J)
PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE)
CROCUS SATIVUS WHOLE (UNII: Z5C927G4XF)
CNIDIUM SEED (UNII: V1IA3S3CUS)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87147-005-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	10/13/2018

Labeler - DANOUS LAND FLOOW LLC (067045402)