BIOELEMENTS AMINO MASK- salicylic acid cream

Bioelements by

Drug Labeling and Warnings

Bioelements by is a Otc medication manufactured, distributed, or labeled by Bioelements, Neutraderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                            Purpose

Salicylic Acid 2%                             Acne Treatment

-For the treatment of acne

-Helps prevent new acne blemishes

-Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

-For External use only

-When using this product: using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. If sensitive to the sun or when increased sun exposure is expected use a sunscreen when using this and other acne products.

-Avoid contact with eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Apply to affected areas only. Do not use on broken skin. Do not apply to large areas of the body.

-Cleanse skin thoroughly before applying

-Use twice a week, apply to skin. Let dry 15 minutes. Rinse Off.

Inactive Ingredients: Water (Aqua) (Eau), Kaolin, Caprylic/Capric Triglyceride, Glycereth-26, Colloidal Sulphur, Salicylic Acid, Chondrus Crispus (carrageenan), Cetearyl Alcohol, Glyceryl Stearate, Dipotassium Glycyrrhizinate, Magnesium Aluminum Silicate, Titanium Dioxide, Bentonite, Camellia Sinensis (Green Tea) Leaf Extract, Niacinamide, Biotin, Panthenol, Allantoin, Vitis Vinifera (White Grape) Fruit Extract, Actinidia Chinensis (Kiwi) Extract, Mel (Honey) Extract (Miel Extrait de mile), Hydrolyzed Yeast Protein, Metha Piperita (Peppermint) Oil, Thuja Occidentalis (Cedar) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Pyroxidine HCL, Glycerin, Ceteareth-20, PEG-100 Stearate, Butylene Glycol, Chlorophensis, Sodium Hydroxide

PRINCIPAL DISPLAY PANEL

Bioelements

Amino Mask

73 mL / 2.5 Fl. Oz.

INGREDIENTS AND APPEARANCE

BIOELEMENTS  AMINO MASK
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
KAOLIN (UNII: 24H4NWX5CO)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERETH-26 (UNII: NNE56F2N14)
SALICYLIC ACID (UNII: O414PZ4LPZ)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BENTONITE (UNII: A3N5ZCN45C)
NIACINAMIDE (UNII: 25X51I8RD4)
BIOTIN (UNII: 6SO6U10H04)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
ACTINIDIA CHINENSIS SEED (UNII: 53V4NSR15J)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GLYCERIN (UNII: PDC6A3C0OX)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-112-02	1 in 1 BOX
1	NDC: 49825-112-01	73 mL in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	01/01/2009

Labeler - Bioelements (174813923)

Registrant - Bioelements (174813923)

Establishment
Name	Address	ID/FEI	Business Operations
Neutraderm, Inc.		146224444	manufacture