Label: TREATONIC NAIL FUNGUS TREATMENT- nail fungus treatment ointment

  • NDC Code(s): 82739-001-01
  • Packager: Shenzhen Situya Trading Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated August 8, 2023

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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

  • INGREDIENTS AND APPEARANCE
    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)
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