ALUMIER MD HYDRASMOOTH NON-COMEDOGENIC MOISTURIZER- salicylic acid cream

Alumier MD HydraSmooth Non-Comedogenic Moisturizer by

Drug Labeling and Warnings

Alumier MD HydraSmooth Non-Comedogenic Moisturizer 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 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, 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

• cleanse skin thoroughly before applying the product
• cover the entire affected area with a thin layer one to three times daily or as directed by your health care practitioner
• if dryness or peeling occurs, reduce application to once a day or every other day

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, Caprylyl Methicone, Propanediol, Dimethicone, Caprylic/Capric Triglyceride, Butylene Glycol, Glycerin, Potassium Cetyl Phosphate, Cetearyl Alcohol, Cocamidopropyl Dimethylamine, Sucrose Stearate, Glyceryl Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Aloe Barbadensis Leaf Juice, Hinokitiol, Sea Whip Extract, Boswellia Serrata Gum Extract, Honey Extract (Extrait de Miel), Oryza Sativa (Rice) 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, Caprylic/Capric Triglyceride, Sorbitan Stearate, Sodium Hydroxide, Disodium EDTA, Xylitol, Citric 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

HydraSmooth

Non-Comedogenic Moisturizer

ACNE TREATMENT

CREAM WITH

1% SALICYLIC ACID

NPN: 80063863

50 mL/1.7 fl oz

INGREDIENTS AND APPEARANCE

ALUMIER MD HYDRASMOOTH NON-COMEDOGENIC MOISTURIZER 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69473-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
PROPANEDIOL (UNII: 5965N8W85T)
SUCROSE STEARATE (UNII: 274KW0O50M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
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)
ALLANTOIN (UNII: 344S277G0Z)
XANTHAN GUM (UNII: TTV12P4NEE)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
.BETA.-THUJAPLICIN (UNII: U5335D6EBI)
HONEY (UNII: Y9H1V576FH)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69473-003-01	1 in 1 CARTON	07/01/2019
1		50 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)