Otc - Active Ingredient
Active Ingredients Purpose
Salicylic Acid 0.5% Acne Treatment
Bioelements
FDA Label NDC 49825-111
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 49825-111). 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, indications & usage, warnings, 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
Indications & Usage
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
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 Ingredient
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 (Back)
Package Label.Principal Display Panel
Bioelements
Acne Clearing System
Active Astringent
88 mL. / 3 Fl. Oz.
Image Of Front Label (Front)
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