Otc - Active Ingredient
Active Ingredients Purpose
Salicylic Acid 2% Acne Treatment
Bioelements
FDA Label NDC 49825-112
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bioelements for the product Bioelements (NDC 49825-112). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
-For the treatment of acne
-Helps prevent new acne blemishes
Otc - Keep Out Of Reach Of Children
-Keep out of reach of children. If swallowed get medical help or contact poison control center right away.
Indications & Usage
-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.
Warnings
-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.
Dosage & Administration
-Cleanse skin thoroughly before applying
-Use twice a week, apply to skin. Let dry 15 minutes. Rinse Off.
Inactive Ingredient
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 (Carton)
Package Label.Principal Display Panel
Bioelements
Amino Mask
73 mL / 2.5 Fl. Oz.
Image Of Front Label (Front)
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