Label: MILIA REMOVER SERUM- milia remover 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 April 7, 2023

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  • Active Ingredient

    amylopectin 1%.

    ammonium 0.8%

  • Purpose

    Disinfectant

  • Use

    fight and reduce signs of milia, alsohelp to resolve acne skin problems.

  • Warnings

    For external use only. Stop using and ask adoctor if rash or irritation happens

  • Do not use

    On broken skin
    On eyes area

  • WHEN USING

    For external use only.
    Avoid contacting with eyes, flush with water immediately if it gets into eyes.
    Children should use it under the supervision of adults.
    Keep out of reach of children.

  • STOP USE section

    lf contact with eyesoccurs, rinse thoroughly with water.Store in a cool, dark place.

  • ASK DOCTOR

    Stop using and ask a doctoif rash or irritation happens.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    Apply gently to skin

  • Inactive ingredients

    glycerol

    salicylic acid

    Dextrin

    xanthan gum

    amylopectin

    tocopherol acetate

    dodecyl dimethybenzyl ammonium

    water

  • PRINCIPAL DISPLAY PANEL

    5985

  • INGREDIENTS AND APPEARANCE
    MILIA REMOVER SERUM 
    milia remover liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83299-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIUM CATION (UNII: 54S68520I4) (AMMONIUM CATION - UNII:54S68520I4) AMMONIUM CATION0.8 mg  in 100 mL
    AMYLOPECTIN (4,5-DIHYDROXY-1,3-DIMETHYLIMIDAZOLIDIN-2-ONE CROSS LINKED) (UNII: 48X4Z23U8J) (AMYLOPECTIN (4,5-DIHYDROXY-1,3-DIMETHYLIMIDAZOLIDIN-2-ONE CROSS LINKED) - UNII:48X4Z23U8J) AMYLOPECTIN (4,5-DIHYDROXY-1,3-DIMETHYLIMIDAZOLIDIN-2-ONE CROSS LINKED)1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.8 mg  in 100 mL
    STARCH, CORN (UNII: O8232NY3SJ) 1 mg  in 100 mL
    DIMETHYLDODECYL(1-NAPHTHYLMETHYL)AMMONIUM CHLORIDE (UNII: 2ZIC77S19B) 10.025 mg  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX) 30 mg  in 100 mL
    XANTHAN GUM (UNII: TTV12P4NEE) 1 mg  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) 10 mg  in 100 mL
    ICODEXTRIN (UNII: 2NX48Z0A9G) 2 mg  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83299-003-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product04/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM00604/05/2023
    Labeler - Consilii LLC (118891890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consilii LLC118891890label(83299-003) , manufacture(83299-003)
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