Otc - Active Ingredient
Active ingredients Purpose
Sulfur 5% Acne treatment
Bioelements
FDA Label NDC 49825-123
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 49825-123). 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 management of acne
Helps prevent acne pimples (and/or acne blemishes, blackheads, whiteheads)
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Indications & Usage
Stop use and ask a doctor
If skin irritation occurs or gets worse
Do not get into eyes
Warnings
Warnings
For external use only
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 medication at a time.
Apply only to areas with acne
Do not use on:
- Broken Skin
- Large areas of the skin
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
Cleanse the Skin thoroughly before applying this product. Cover the entire affected area with a thin layer and let dry 15 minutes then rinse well. Use twice a week. Because excessive drying of the skin may occur, start with one application, then gradually increase to two times a week if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application or discontinue use.
Inactive Ingredient
Inactive ingredientsWater (Aqua) (Eau), Kaolin, Caprylic/Capric Triglyceride, Glycerin, Cetearyl Alcohol, Ceteareth-20, Glyceryl Stearate, PEG-100 Stearate, Dipotassium Glycyrrhizate, Lactic Acid, Bentonite, Chondrus Crispus (Carrageenan), Titanium Dioxide (CI 77891), Lavendula Angustifolia (Lavender) Oil, Camellia Sinensis (Green Tea) Leaf Extract, Vitis Vinifera (Grape) Fruit Extract, Actinidia Chinensis (Kiwi) Extract, Mel (Honey) Extract (Miel Extrait de Mile), Niacinamide, Biotin, Panthenol, Allantoin, Pyroxidine HCL, Hydrolyzed Soy Protein, Phenoxyethanol, Ethylhexylglycerin.
Package Label.Principal Display Panel
Bioelements
Amino Mask (R)
Sulfur Acne Treatment Mask with Lactic Acid
73 mL / 2.5 Fl. Oz.
Image Of Jar Artwork (Jar)
* Please review the disclaimer below.
