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Name:Bioelementsamino Mask
Manufacturer:Bioelements
Category:Over-the-counter (OTC) Marketed Drugs


Amino Mask

BIOELEMENTS AMINO MASK - salicylic acid cream 
Bioelements

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Amino Mask

Active Ingredients                     Purpose

Salicylic Acid 2%                      Acne Treatment


Warnings

-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.

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

-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.

Uses

-For the treatment of acne

-Helps prevent new acne blemishes


Directions

-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

image of carton

Bioelements

Amino Mask

73 mL / 2.5 Fl. Oz.

image of front label


BIOELEMENTS  AMINO MASK
salicylic acid cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49825-112
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49825-112-02 1 JAR ( JAR) in 1 BOX contains a JAR (49825-112-01)
1 NDC:49825-112-01 73 mL in 1 JAR This package is contained within the BOX (49825-112-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333 01/01/2009

Labeler - Bioelements (174813923)
Registrant - Bioelements (174813923)
Establishment
Name Address ID/FEI Operations
Bioelements 174813923 manufacture

Revised: 06/2010 Bioelements



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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