Treatonic Nail Fungus Treatment by Shenzhen Situya Trading Co., Ltd. 82739-001 Complete

Treatonic Nail Fungus Treatment by

Drug Labeling and Warnings

Treatonic Nail Fungus 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]

TREATONIC NAIL FUNGUS TREATMENT- nail fungus treatment ointment 
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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82739-001 Complete

Active ingredient

Miconazole Nitrate 2%

Purpose

Antifungal

Uses

Proven effective in the treatment of mostathlete s foot (tinea pedis) and tinea corporis (ringworm).

For effective relief of itching, burning, and cracking.

Warnings

For external use only .

If pregnant or breastfeeding consult a healthcareprofessional before use

Do not use

on children under 2 vears of age unlessdirected by a doctor.

When using this product

avoid contact with the eyes . Ifeyes contact occurs , rinse thoroughly with water .

Stop use

Stop use and consult a doctor if

Irritation occurs.

there is no improvement within 4 Weeks.

KEEP OUT OF

KEEP OUT OF REACH OF CHILDREN.

If accidental ingestion occurs , get medical help or contacta Poison Control Center right away

Directions

Directions Use only as directedAdults and children 12 years and older:

Thoroughlyash and dry the affected areas

Gently rotate the endof the pen (around 10s) to dispense the product onto thebrush applicator.

Apply a thin layer of liquid directlyover affected areas and surrounding cuticle areas 2times (morning and night) daily or as directed by a doctor.

Depending on the condition of the affected area , use itdaily for 2-4 weeks

Children under 12 years: ask a doctor

Other information

Store at room temperature15-30℃ ( 59-86℉ ) Protect from freezing . If freezing occurs , warm to room temperature . Keep tightly closed when not in use

Inactive ingredients

water , ethanol , propylene glycol ,chlorhexidine acetate , laurocapram ,xanthan gum , acetic acid , deacetylated chitin ,O-hydroxybenzoic acid , Chinese angelica , root ofDahurian angelica , Hydroxybenzyl.

Package Label-principal Display Panel

TREATONIC NAIL FUNGUS TREATMENT 
nail fungus treatment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82739-001
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)
LAUROCAPRAM (UNII: 1F3X9DRV9X)
CHITIN (UNII: 8SH93A7QWW)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
XANTHAN GUM (UNII: TTV12P4NEE)
4-HYDROXYBENZYL ALCOHOL (UNII: 1A3AH1FP1B)
ACETIC ACID (UNII: Q40Q9N063P)
ANGELICA SINENSIS ROOT (UNII: B66F4574UG)
ANGELICA DAHURICA LEAF (UNII: ONF5ZKM88G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82739-001-01	3 mL in 1 BOX; Type 1: Convenience Kit of Co-Package	05/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/19/2022	12/23/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Shenzhen Situya Trading Co., Ltd.		706154255	manufacture(82739-001)

Revised: 12/2024

Document Id: 29eab137-3d19-1c2e-e063-6294a90aff4a

34390-5

Set id: df5b24b0-9c86-947a-e053-2a95a90a0e1d

Version: 6

Effective Time: 20241223