ALUMIER MD ACNE CLARIFYING CLEANSER- salicylic acid gel

Alumier MD Acne Clarifying Cleanser by

Drug Labeling and Warnings

Alumier MD Acne Clarifying Cleanser by is a Otc medication manufactured, distributed, or labeled by Alumier Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Salicylic Acid 2.0%

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, consult a health care professional

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

Directions

• 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

• 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, 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

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

Alumier MD

Acne Clarifying Cleanser

ACNE TREATMENT WITH 2%

SALICYLIC ACID

NPN: 80064465

177 mL/6 fl oz

INGREDIENTS AND APPEARANCE

ALUMIER MD ACNE CLARIFYING CLEANSER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69473-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC ACID (UNII: OBL58JN025)
OLIGOPEPTIDE-10 (UNII: Q46328TRNK)
PROPANEDIOL (UNII: 5965N8W85T)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
GLYCERYL CAPRATE (UNII: 197M6VFC1W)
HONEY (UNII: Y9H1V576FH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
RICE BRAN (UNII: R60QEP13IC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-001-01	1 in 1 CARTON	07/01/2019
1		177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	07/01/2019

Labeler - Alumier Labs (079603173)