Label: HEALTHYDERM MOLLUSCUM CONTAGIOSUM TREATMENT OIL- molluscum contagiosum treatment oil

  • NDC Code(s): 82739-009-01
  • Packager: Shenzhen Situya Trading Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 4, 2023

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  • Active Ingredient

    SALICYLIC ACID 1%

  • Purpose

    Skin Conditioner

  • Use

    Helpful as an aid to treat the symptoms of molluscum contagiosum.

  • Warnings

    For external use only.

  • Do not use

    On irritated skin on any area that is infected or reddened
    Do not use it if pregnant or if there is any allergic reaction to thisproduct
    Avoid contact with eyes.

  • WHEN USING SECTION

    Symptoms of molluscum contagiosum.

  • STOP USE section

    if you have diabetes or poor blood circulation

  • ASK DOCTOR

    if you have diabetes or poor blood circulation

  • KEEP OUT OF REACH OF CHILDREN

    lf product gets into eyes, flush with water for 15 minutes
    lf swallowed, get medical help or contact a Poison Control Centerright away.

  • Directions

    Wash affected areas and dry thoroughly.
    Apply the product 3to 4 times daily to the affected area using the brush applicator.Allow to dry completely.
    Over the next 1 to 2 weeks, Mollus-cum warts will start to redden and scab over.
    Molluscum pap-ules will then diminish, dry up and flake away over a 2-6 weeksperiod.

  • Inactive ingredients

    WATER
    SILVER NITRATE
    ECHINACEA ANGUSTIFOLIA EXTRACT
    FUCUS VESICULOSUS EXTRACT
    THUJA OCCIDENTALIS BARK EXTRACT
    MELALEUCA ALTERNIFOLIA TEA TREE LEAF OIL
    MENTHOLUM

    CAMPHOR SYNTHETIC

  • QUESTIONS?

    PRIMEDERMLLC
    CHEYENNE WY 82001
    service@ihealthyderm.com
    www.ihealthyderm.com
    1 307 461 0868

  • PRINCIPAL DISPLAY PANEL

    82739-009-01

    82739-008-01

  • INGREDIENTS AND APPEARANCE
    HEALTHYDERM MOLLUSCUM CONTAGIOSUM TREATMENT OIL 
    molluscum contagiosum treatment oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82739-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILVER NITRATE (UNII: 95IT3W8JZE)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    FUCUS VESICULOSUS (UNII: 535G2ABX9M)  
    THUJA OCCIDENTALIS BARK (UNII: 19RAD88E6O)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)  
    WATER (UNII: 059QF0KO0R)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82739-009-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product04/20/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02804/20/2023
    Labeler - Shenzhen Situya Trading Co., Ltd. (706154255)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shenzhen Situya Trading Co., Ltd.706154255manufacture(82739-009)
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