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Name:Bioelementsactive Astringent
Manufacturer:Bioelements
Category:Prescription Marketed Drugs


Active Astringent

BIOELEMENTS ACTIVE ASTRINGENT - salicylic acid liquid 
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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Active Astringent

Active Ingredients                  Purpose

Salicylic Acid  0.5%               Acne Treatment

Uses:

-For the treatment of acne

-Helps prevent new acne blemishes


Directions

-Cleanse skin thoroughly before applying

-Apply to cotton pad and wipe over skin, avoiding eye area.


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 center right away.

Inactive Ingredients: Water (Aqua) (Eau), Hamamelis Virginiana (Witch Hazel) Extract, SD Alcohol, Pentylene Glycol, Hexylene Glycol, Glycerin, Vitis Vinifera (Grape) Fruit Extract, Mel (Honey) Extract (Miel Extrait de mile), Potassium Hydroxide, Actinidia Chinensis (Kiwi) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Anenas Sativus (Pineapple) Fruit Extract, Lavandula Angustifolia (Lavender) Extract, Citrus Medica Limonum (Lemon) Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Aurantium Dulcis (Orange) Fruit Extract, Citrus Grandis (Grapefruit) Fruit Extract, Lavendula Hybrida (Lavandin) Oil, Tetrahexadecyl Ascorbate, Methylisothiazolinone, Chlorphenesin

image of back carton

Bioelements

Acne Clearing System

Active Astringent

88 mL. / 3 Fl. Oz.

image of front label


BIOELEMENTS  ACTIVE ASTRINGENT
salicylic acid liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49825-111
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.5 mL  in 100 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49825-111-02 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE (49825-111-01)
1 NDC:49825-111-01 88 mL in 1 BOTTLE This package is contained within the BOX (49825-111-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 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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