Label: MEOLY MILIA REMOVER SERUM- milia remover serum liquid

  • 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 August 17, 2023

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  • Active Ingredient

    Didecyl dimethyl 0.025%

  • Purpose

    Disinfectant

  • Use

    temporarily relieves these symptoms dueto hay fever or other upper respiratory allergies

  • Warnings

    For external use only. Stop using and ask a doctorif rash or irritation happens.

  • 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 this product - Avoid contact with eyes.

  • When Using

    For external use only Stop using and ask a doctorif rash or irritation happens.

  • Stop Use

    Stop using and ask a doctorif rash or irritation happens. If contact with eyesoccurs, rinse thoroughly with water, Store in a coolshady place.

  • Keep Oot Of Reach Of Children

    If product gets into eyes, flush with water for 15 minutes

    If swallowed, get medical help or contact a Poison Control Center right away

  • Ask Doctor

    Stop using and ask a doctorif rash or irritation happens.

  • Directions

    Apply daily after cleansing and toning. Twice a day for at least 4 weeks.
    Dispense a pea-size amount of the essence onto the problematic area and use fingertips to massage until fully absorbed.
    Keep using it for a period of time until the milia doesn’t appear again.

  • Inactive ingredients

    Glycerin, salicyle acid, dextrin,xanthan gum, amylopectin, tocopheryl acetate, dodecyl dimethyl benzyl ammonium chloride 0.025% ± 10%

  • PACKAGE LABEL

    01

  • INGREDIENTS AND APPEARANCE
    MEOLY MILIA REMOVER SERUM 
    milia remover serum liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83299-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIDECYLDIMONIUM (UNII: Z7F472XQPA) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    AMYLOPECTIN, CORN (UNII: TQI9LJM246)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83299-013-0130 g in 1 BOTTLE; Type 0: Not a Combination Product08/14/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00508/14/2023
    Labeler - Consilii LLC (118891890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consilii LLC118891890manufacture(83299-013) , label(83299-013)
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