FDA.reportPublic FDA data

Alumier MD Acne Clarifying Cleanser

Manufacturer
Alumier Labs
Effective date
2024-12-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:40:09

Label at a glance#

ProductAlumier MD Acne Clarifying Cleanser
Active ingredientSALICYLIC ACID
Label structure9 sections

Dosage and administration

use twice daily, in the morning and evening moisten face with lukewarm water pump a small amount into your hand add water and apply to your face and neck, massaging in a circular motion rinse thoroughly with lukewarm water and gently pat dry 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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

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, consult a health care professional

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

  • use twice daily, in the morning and evening
  • moisten face with lukewarm water
  • pump a small amount into your hand
  • add water and apply to your face and neck, massaging in a circular motion
  • rinse thoroughly with lukewarm water and gently pat dry

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

  • 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, Sodium C14-16 Olefin Sulfonate, Propanediol, Dimethyl Lauramide/Myristamide, Glycerin, Cocamidopropyl Dimethylamine, Cocamidopropyl Hydroxysultaine, Glyceryl Caprate, Lauryl Lactyl Lactate, Oligopeptide-10, Aloe Barbadensis Leaf Juice, Boswellia Serrata Gum Extract, Honey Extract (Extrait de Miel), Oryza Sativa (Rice) Bran Extract, Carbomer, Sodium Hydroxide, Disodium EDTA, Caprylyl Glycol, Xylitol, Caprylic Acid, Ethylhexylglycerin.

Company Information

SPL UNCLASSIFIED SECTION

ALUMIER EUROPE LTD.

5 ST. FREDERICK STREET

VALLETTA VLT 1470, MALTA

WWW.ALUMIERMD.COM

EUROPE • UNITED STATES • CANADA

UNITED KINGDOM

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

Alumier MD

Acne Clarifying Cleanser

ACNE TREATMENT WITH 2%

SALICYLIC ACID

NPN: 80064465

177 mL/6 fl oz

acne clarifying cleanser revacne clarifying cleanser rev

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN3
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD3
562600salicylic acid 2 % Facial Cleanser TonerSY3
562600salicylic acid 2 % Facial ScrubSY3
562600salicylic acid 2 % Medicated Liquid SoapSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69473-001-01Alumier MD Acne Clarifying Cleanser1 in 1 CARTONGEL13
69473-001-01Alumier MD Acne Clarifying Cleanser177 mL in 1 BOTTLE, PUMPGEL1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69473-001ALUMIER MD ACNE CLARIFYING CLEANSER (SALICYLIC ACID) GEL [ALUMIER LABS]3Current NDC, Legacy NDC, 2 package rows20241204_87747f82-9018-ab34-e053-2995a90a6808.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69473-00169473-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZACTIB
CAPRYLIC ACIDOBL58JN025IACT
PROPANEDIOL5965N8W85TIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
GLYCERYL CAPRATE197M6VFC1WIACT
OLIGOPEPTIDE-10Q46328TRNKIACT
HONEYY9H1V576FHIACT
EDETATE DISODIUM7FLD91C86KIACT
COCAMIDOPROPYL DIMETHYLAMINEL36BM7DG2TIACT
ALOE VERA LEAFZY81Z83H0XIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERINPDC6A3C0OXIACT
RICE BRANR60QEP13ICIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
SODIUM HYDROXIDE55X04QC32IIACT
XYLITOLVCQ006KQ1EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT

Source Document#

Source XML

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
Alumier MD Acne Clarifying CleanserSALICYLIC ACIDAlumier Labs87747f82-9018-ab34-e053-2995a90a68082024-12-01WarningsExact identifier
ndc (package): 69473-001-01
ndc (product): 69473-001
ndc11 (package): 69473000101
spl id: 284093cf-80e1-38d4-e063-6394a90a1881
spl set id: 87747f82-9018-ab34-e053-2995a90a6808

Reported adverse events (FAERS/openFDA)#

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