MILIA REMOVER SERUM- milia remover liquid 
Consilii LLC

----------

83299-003 Completed
Milia Remover Serum

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

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 DrugM00604/05/202308/29/2024
Labeler - Consilii LLC (118891890)
Establishment
NameAddressID/FEIBusiness Operations
Consilii LLC118891890label(83299-003) , manufacture(83299-003)

Revised: 8/2024
Document Id: 20d140c3-79c9-c910-e063-6394a90aa571
Set id: f8bac722-88e4-7431-e053-6294a90ac130
Version: 2
Effective Time: 20240829
 
Consilii LLC