Otc - Active Ingredient
Active ingredient Purpose
Salicylic Acid 0.5% Acne treatment
Acne Toner
FDA Label NDC 49825-130
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, Inc. for the product Acne Toner (NDC 49825-130). 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
Uses
For the treatment of acne
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
When using this product: Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Warnings
warnings
For external use only
Dosage & Administration
Directions
Use after cleansing, day and night, avoiding eye area. Apply to cotton pad and gently wipe over skin. Do not rinse. If dryness or peeling occurs, reduce usage to once a day.
Inactive Ingredient
Inactive ingredients
Water (Aqua, Eau), Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, SD Alcohol, Pentylene Glycol, Hexylene Glycol, PEG-40 Hydrogenated Castor Oil, Glycerin, Vitis Vinifera (Grape) Fruit Extract, Mel (Honey) Extract (Miel Extrait de mile), Sodium Hydroxide, Ananas Sativus (Pineapple) Fruit Extract, Citrus Medica Limonium (Lemon) Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Lavandula Angustifolia(Lavender) Extract, Citrus Grandis (Grapefruit) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Actinidia Chinensis (Kiwi) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Citrus Grandis (Grapefruit) Peel Oil, Canarium Luzonicum Gum Nonvolatiles, Citrus Aurantium Dulcis (Orange) Oil, Caprylic/Capric Triglyceride, Lavandula Hybrida (Lavandin) Oil, Tetrahexyldecyl Ascorbate, Ethylhexylglycerin, Phenoxyethanol.
Package Label.Principal Display Panel
Label (Label)
Primary (Primary)
Secondary (Secondary)
Biolelements
Acne Clearing System
Acne Toner
0.5% salicylic acid acne treatment
Hydrates, clears and eliminates excess oil
88 mL / 3 Fl Oz
* Please review the disclaimer below.
