Label: BIOELEMENTS AMINO MASK- salicylic acid cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 49825-112-01, 49825-112-02 - Packager: Bioelements
- Category: HUMAN OTC 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 March 22, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Active Ingredients Purpose
Salicylic Acid 2% Acne Treatment
-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
-
INGREDIENTS AND APPEARANCE
BIOELEMENTS AMINO MASK
salicylic acid creamProduct 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
