FDA.reportPublic FDA data

Alumier MD HydraSmooth Non-Comedogenic Moisturizer

Manufacturer
Alumier Labs
Effective date
2023-10-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:22:57

Label at a glance#

ProductAlumier MD HydraSmooth Non-Comedogenic Moisturizer
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.0%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

  • for the treatment of acne

Warnings

WARNINGS SECTION

  • For external use only.

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69473-00369473-003-01, 69473-003-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)R9TPS68K19IACT
CAPRYLIC ACIDOBL58JN025IACT
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
PROPANEDIOL5965N8W85TIACT
SUCROSE STEARATE274KW0O50MIACT
FU LINGXH37TWY5O4IACT
WATER059QF0KO0RIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALLANTOIN344S277G0ZIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
COCAMIDOPROPYL DIMETHYLAMINEL36BM7DG2TIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
RESVERATROLQ369O8926LIACT
XANTHAN GUMTTV12P4NEEIACT
HONEYY9H1V576FHIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
.BETA.-THUJAPLICINU5335D6EBIIACT
RICE BRANR60QEP13ICIACT
OLIGOPEPTIDE-10Q46328TRNKIACT
FILIPENDULA ULMARIA WHOLE3LH0M209LNIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SALICYLIC ACIDO414PZ4LPZACTIB
TRICAPRYLIN6P92858988IACT
SODIUM HYDROXIDE55X04QC32IIACT
XYLITOLVCQ006KQ1EIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
18bbe1f5-5031-f8fd-e063-6294a90ae72c884ec328-b213-7e61-e053-2995a90ab9892024-05-18WarningsExact identifier
spl set id: 884ec328-b213-7e61-e053-2995a90ab989

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.