FUNGAL NAIL REPAIR- acetic acid liquid

FUNGAL NAIL REPAIR by

Drug Labeling and Warnings

FUNGAL NAIL REPAIR by is a Otc medication manufactured, distributed, or labeled by Shenzhen Furuizhilian keji Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACETIC ACID 17%

PURPOSE

Antifungal

KEEP OUT OF REACH OF CHILDREN

Keep out ofreach ofchildren

INDICATIONS & USAGE

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

WARNINGS

Flammable, keep away from fire and flames
For external use only

DOSAGE & ADMINISTRATION

Apply it in the day and night
Before using it for the first time, soak thediseased nail with warm water to soften it,use the nail file to polish the nail, make itthin visibly, and scrape off the dirt on thenail (be careful not to hurt the nail bed),then apply the liquid
After first use, every 2-3 days, use the nailfille to polish the surface of the diseasednail and then continue to use it

STORAGE AND HANDLING

Store at 59-86 °F(15-30°C)

INACTIVE INGREDIENT

Water, Alcohol, Phryma Leptostachya Extract,Salicylic Acid, Sophora Flavescens RootExtract, Garden Balsam (Impatiens Balsamina)Leaf Extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FUNGAL NAIL REPAIR 
acetic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84445-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P)	ACETIC ACID	17 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
SALICYLIC ACID (UNII: O414PZ4LPZ)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
PHRYMA LEPTOSTACHYA WHOLE (UNII: 6G287VJM69)
IMPATIENS BALSAMINA LEAF (UNII: LH9E1X602V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84445-001-01	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2024
2	NDC: 84445-001-02	35 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	06/26/2024

Labeler - Shenzhen Furuizhilian keji Co., Ltd. (418598613)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Furuizhilian keji Co., Ltd.		418598613	manufacture(84445-001)