Label: BIOELEMENTS ACTIVE ASTRINGENT- salicylic acid liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 49825-111-01, 49825-111-02 - Packager: Bioelements
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 11, 2010
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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
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INGREDIENTS AND APPEARANCE
BIOELEMENTS ACTIVE ASTRINGENT
salicylic acid liquidProduct 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
