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, get medical help or contact a Poison Control Centre 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 a 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, Dimethyl Isosorbide, Propanediol, Niacinamide, Glyceryl Caprate, Hinokitiol, Sea Whip Extract, Oryza Sativa (Rice) Bran Extract, Boswellia Serrata Gum Extract, Aloe Barbadensis Leaf Juice, Caprylic Acid, Caprylyl Glycol, Sodium Hyaluronate, Glycerin, Resveratrol, Oligopeptide-10, Honey Extract (Extrait de Miel), Allantoin, Ammonium Acryloyldimethyltaurate/VP Copolymer, Allyl Methacrylates Crosspolymer, Xanthan Gum, Cetyl Hydroxyethylcellulose, Pentylene Glycol, Disodium EDTA, Polymethyl Methacrylate, Tricaprylin, Sodium Hydroxide, Xylitol, Ethylhexylglycerin.

Product Packaging

Alumier MD

Acne Balancing Serum

ACNE TREATMENT

WITH 2% SALICYLIC ACID

NPN: 80063862

30 mL/1 fl oz

acne balancing serum

ALUMIER MD ACNE BALANCING SERUM
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69473-002
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLIC ACID (UNII: OBL58JN025)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
RESVERATROL (UNII: Q369O8926L)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TRICAPRYLIN (UNII: 6P92858988)
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
PROPANEDIOL (UNII: 5965N8W85T)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
OLIGOPEPTIDE-10 (UNII: Q46328TRNK)
HONEY (UNII: Y9H1V576FH)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERYL CAPRATE (UNII: 197M6VFC1W)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)
RICE BRAN (UNII: R60QEP13IC)
.BETA.-THUJAPLICIN (UNII: U5335D6EBI)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69473-002-01	1 in 1 CARTON	07/01/2019
1		30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

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

Labeler - Alumier Labs (079603173)

Alumier MD Acne Balancing Serum