BIOELEMENTS ACTIVE ASTRINGENT- salicylic acid liquid

Bioelements by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

Bioelements

Acne Clearing System

Active Astringent

88 mL. / 3 Fl. Oz.

INGREDIENTS AND APPEARANCE

BIOELEMENTS  ACTIVE ASTRINGENT
salicylic acid liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 49825-111
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-111-02	1 in 1 BOX
1	NDC: 49825-111-01	88 mL in 1 BOTTLE

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	Business Operations
Bioelements		174813923	manufacture