Label: DR. LUKE FUNGAL NAIL RENEWAL- fungal nail renewal liquid
- NDC Code(s): 83176-006-01
- Packager: Dr.luke Healthcare LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 8, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
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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
- WHEN USING SECTION
- STOP USE section
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR. LUKE FUNGAL NAIL RENEWAL
fungal nail renewal liquidProduct 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 final M005 04/06/2023 Labeler - Dr.luke Healthcare LLC (118868014) Establishment Name Address ID/FEI Business Operations Dr.luke Healthcare LLC 118868014 label(83176-006) , manufacture(83176-006)
