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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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

82739-001-01

TREATONIC NAIL FUNGUS TREATMENT 
nail fungus treatment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82739-001
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)  
LAUROCAPRAM (UNII: 1F3X9DRV9X)  
CHITIN (UNII: 8SH93A7QWW)  
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)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82739-001-013 mL in 1 BOX; Type 1: Convenience Kit of Co-Package05/19/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/19/2022
Labeler - Shenzhen Situya Trading Co., Ltd. (706154255)
Establishment
NameAddressID/FEIBusiness Operations
Shenzhen Situya Trading Co., Ltd.706154255manufacture(82739-001)

Revised: 8/2023
Document Id: 02660c3e-1a63-e31e-e063-6294a90aec59
Set id: df5b24b0-9c86-947a-e053-2a95a90a0e1d
Version: 5
Effective Time: 20230808
 
Shenzhen Situya Trading Co., Ltd.