FUNGAL NAIL TREATMENT by Shenzhen Situya Trading Co., Ltd.

FUNGAL NAIL TREATMENT by

Drug Labeling and Warnings

FUNGAL NAIL TREATMENT by is a Otc medication manufactured, distributed, or labeled by Shenzhen Situya Trading Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FUNGAL NAIL TREATMENT- fungal nail treatment solution/ drops 
FUNGAL NAIL TREATMENT- natural vine fungal nail treatment cream 
Shenzhen Situya Trading Co., Ltd.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active Ingredient

Pseudolarix Amabilis Bark 1%
Stemona Japonica Root 2%
Coptis Chinensis Root 1%
Sophora Flavescens Root 1.5%
Atractylodes Lancea Root 1%
Borneol 1.5%

Dictamnus Dasycarpus Root Bark1.5%

Camphor (Natural)1%

Propylene Glycol1.5%
Salicylic Acid 1%

Use

Hinder fungal and bacterial growth, reduces itching. cleanse skin tissue.

Warnings

For external use only.

Do not use

on irritated skin on any area that is infected orreddened Do not use it if pregnant or if there is any allergicreaction to this product. Avoid contact with eyes.

STOP USE section

if discomfort persists

KEEP OUT OF REACH OF CHILDREN

lf product gets into eyes, flushwith water for 15 minutes lf swallowed, get medical help orcontact a Poison Control Center right away

ASK DOCTOR

if you have diabetes or poorblood circulation

Directions

Wash feet thoroughly with warm water, and gentlyfile thickened part of the fungal nail with a nail file until it's flatApply a layer of the liquid to the surface of the fungal nailand allow it to be absorbed into the nail After the liquid hasbeen absorbed, apply a layer of the cream to the infected partsof the nail. Repeat the process if necessary, once a day.

Other information

Store at room temperature and out ofdirect sunlight Skin discoloration may occur during or after use

Inactive ingredients

Water, Camphor Natural,DictamnusDasycarpus Root Bark, Propylene Glycol, White Petrolatum.Camphor Oil, White, Stearic Acid

QUESTIONS

NEWMIST LLCEARTH CITYMISSOURI 63045

www.inaturalvine.com

1-636-725 9720

PURPOSE

Antifungal

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

82739-004-01

FUNGAL NAIL TREATMENT 
fungal nail treatment solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82739-004
Route of Administration	EXTRACORPOREAL, CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) (SOPHORA FLAVESCENS ROOT - UNII:IYR6K8KQ5K)	SOPHORA FLAVESCENS ROOT	1.5 g  in 100 mL
DICTAMNUS DASYCARPUS ROOT BARK (UNII: LA97176ILS) (DICTAMNUS DASYCARPUS ROOT BARK - UNII:LA97176ILS)	DICTAMNUS DASYCARPUS ROOT BARK	1.5 g  in 100 mL
STEMONA JAPONICA ROOT (UNII: FXG254HF10) (STEMONA JAPONICA ROOT - UNII:FXG254HF10)	STEMONA JAPONICA ROOT	2 g  in 100 mL
COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL) (COPTIS CHINENSIS ROOT - UNII:CXS4LJR7EL)	COPTIS CHINENSIS ROOT	1 g  in 100 mL
ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O) (ATRACTYLODES LANCEA ROOT - UNII:CAZ6282J2O)	ATRACTYLODES LANCEA ROOT	1 g  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 mL
PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE) (PSEUDOLARIX AMABILIS BARK - UNII:49G13A93VE)	PSEUDOLARIX AMABILIS BARK	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82739-004-01	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/22/2023	03/25/2023

FUNGAL NAIL TREATMENT 
natural vine fungal nail treatment cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82739-005
Route of Administration	CUTANEOUS, EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	1.5 g  in 100 g
STEMONA JAPONICA ROOT (UNII: FXG254HF10) (STEMONA JAPONICA ROOT - UNII:FXG254HF10)	STEMONA JAPONICA ROOT	2 g  in 100 g
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) (SOPHORA FLAVESCENS ROOT - UNII:IYR6K8KQ5K)	SOPHORA FLAVESCENS ROOT	1.5 g  in 100 g
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	1 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 g
PSEUDOLARIX AMABILIS BARK (UNII: 49G13A93VE) (PSEUDOLARIX AMABILIS BARK - UNII:49G13A93VE)	PSEUDOLARIX AMABILIS BARK	1 g  in 100 g
COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL) (COPTIS CHINENSIS ROOT - UNII:CXS4LJR7EL)	COPTIS CHINENSIS ROOT	1 g  in 100 g
ATRACTYLODES LANCEA ROOT (UNII: CAZ6282J2O) (ATRACTYLODES LANCEA ROOT - UNII:CAZ6282J2O)	ATRACTYLODES LANCEA ROOT	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82739-005-01	20 g in 1 BOTTLE; Type 0: Not a Combination Product	03/22/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/22/2023	03/25/2023

Labeler - Shenzhen Situya Trading Co., Ltd. (706154255)

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Situya Trading Co., Ltd.		706154255	manufacture(82739-004, 82739-005)

Revised: 4/2023

Document Id: f9fcfdb1-44ab-955f-e053-6394a90a281d

34390-5

Set id: f77875ee-2a26-c7a6-e053-6294a90ac05c

Version: 2

Effective Time: 20230423