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.

Product Packaging

Alumier MD

Acne Clarifying Cleanser

ACNE TREATMENT WITH 2%

SALICYLIC ACID

NPN: 80064465

177 mL/6 fl oz

acne clarifying cleanser rev

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 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 Clarifying Cleanser