ALUMIER MD HYDRASMOOTH NON-COMEDOGENIC MOISTURIZER- salicylic acid cream 
Alumier Labs

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Alumier MD HydraSmooth Non-Comedogenic Moisturizer

Drug Facts

Active Ingredient

Salicylic Acid 1.0%

Purpose

Acne treatment

Use

  • for the treatment of acne

Warnings

  • For external use only.

When using this product​

  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • skin irritation and dryness is more likely to occur if you use another topical acne product at the same time. If irritation occurs, only use one topical acne product at a time.

Stop use and ask a doctor if you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing.

  • for more severe cases, and/or if improvement is not apparent within 6-8 weeks

Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.

Directions

  • for adults 18 years and older
  • cleanse skin thoroughly before applying the product

For New Users

  • apply product to a small area once a day for three days to test if you are sensitive to this product
  • if no discomfort occurs, cover the entire affected area with a thin layer
  • start with one application daily, then gradually increase to two to three times daily, if needed
  • if dryness or peeling occurs, reduce application to once a day or every other day.

Other information

  • Store in a cool, dry place at room temperature
  • Do not use if security seal is broken or missing
  • You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 550 Cochituate Road, Suite 25, Framingham, MA 01701

Inactive Ingredients

Water/Aqua/Eau, Propanediol, Caprylyl Methicone, Dimethicone, Caprylic/Capric Triglyceride, Butylene Glycol, Glycerin, Cetearyl Alcohol, Cocamidopropyl Dimethylamine, Potassium Cetyl Phosphate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Glyceryl Stearate, Sucrose Stearate, Aloe Barbadensis Leaf Juice, Hinokitiol, Poria Cocos Extract, Boswellia Serrata Gum Extract, Honey Extract (Extrait de Miel), Oryza Sativa Bran Extract, Resveratrol, Allantoin, Oligopeptide-10, Spiraea Ulmaria Extract, Tocopheryl Acetate, Sodium Hyaluronate, Polysilicone-11, Polymethyl Methacrylate, Adipic Acid/Diglycol Crosspolymer, Tricaprylin, Caprylyl Glycol, Xanthan Gum, Caprylic Acid, Sorbitan Stearate, Sodium Hydroxide, Disodium EDTA, Tocopherol, Xylitol, Citric Acid, Ethylhexylglycerin.

Company Information

ALUMIER EUROPE LTD.

VISION EXCHANGE BUILDING

TERRITORIALS STREET

ZONE 1, CENTRAL BUSINESS DISTRICT

BIRKIRKARA CBD 1070, MALTA

WWW.ALUMIERMD.COM

DISTRIBUTED IN CANADA BY

ALUMIER LABS INC.,

436 LIMESTONE CRESCENT

TORONTO, ON, M3J 2S4

DISTRIBUTED IN THE USA BY

ALUMIER LABS INC.,

550 COCHITUATE ROAD, SUITE 25

FRAMINGHAM, MA 01701

MANUFACTURED IN CANADA UNDER

LICENSE FROM ALUMIER EUROPE LTD.

Product Packaging

1

ALUMIER MD HYDRASMOOTH NON-COMEDOGENIC MOISTURIZER 
salicylic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69473-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
CAPRYLIC ACID (UNII: OBL58JN025)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
PROPANEDIOL (UNII: 5965N8W85T)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
FU LING (UNII: XH37TWY5O4)  
WATER (UNII: 059QF0KO0R)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALLANTOIN (UNII: 344S277G0Z)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
RESVERATROL (UNII: Q369O8926L)  
XANTHAN GUM (UNII: TTV12P4NEE)  
HONEY (UNII: Y9H1V576FH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
.BETA.-THUJAPLICIN (UNII: U5335D6EBI)  
RICE BRAN (UNII: R60QEP13IC)  
OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
FILIPENDULA ULMARIA WHOLE (UNII: 3LH0M209LN)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
TRICAPRYLIN (UNII: 6P92858988)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
XYLITOL (UNII: VCQ006KQ1E)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69473-003-011 in 1 CARTON07/01/201912/01/2023
150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:69473-003-021 in 1 CARTON12/01/2023
250 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00607/01/201901/31/2024
Labeler - Alumier Labs (079603173)

Revised: 5/2024
Document Id: 18bbe1f5-5031-f8fd-e063-6294a90ae72c
Set id: 884ec328-b213-7e61-e053-2995a90ab989
Version: 4
Effective Time: 20240518
 
Alumier Labs