Otc - Active Ingredient
Active ingredient Purpose
Benzoyl Peroxide 5% Acne treatment
Breakout Control
FDA Label NDC 49825-124
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 Breakout Control (NDC 49825-124). 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
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 a poison control center right away
Indications & Usage
Stop use and ask a doctor if:
irritation becomes severe
Warnings
Warnings
For external use only
When using this product
- Skin irritation and dryness is more likely to occur if you use antoher topical acne medication at the same time. If irritation occurs only use only one topical acne medication at a time.
- Avoid unnecessary sun exposure and use a sunscreen
- Avoid contact with with the eyes lips and mouth
- Avoid contact with hair and dyed fabrics, which may be bleached by this product
- Skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling . Irritation may be reduced by using the product less frequently or in a lower concentration.
- Do not use if you:
Have very sensitive skin
Are sensitive to benzoyl peroxideDosage & Administration
Directions
Cleanse the skin thoroughly before applying this product
cover the entire with a thin layer one to three times daily
Because excessive drying of the skin may occur, start with one application daily then gradually increase to two or three times daily if needed or as directed by a doctor
If bothersome dryness or peeling occurs, reduce application to once a day or every other day
If going outside apply sunscreen after using this product. If irritation or sensitivity develops stop use of both products and ask a doctor.
Inactive Ingredient
Inactive ingredients
Water (Aqua,Eau), Pentylene Glycol, Hydroxyethyl Acrylates/Sodium Acryloyldimethyl Taurate Copolymer, Squalene, Polysorbate 60, Aloe Bardadensis (Aloe) Leaf Juice powder, Phytic Acid, Phyenoxyethanol, Potassium Sorbate, Disodium EDTA.
Image Of Secondary Artwork (Secondary)
Package Label.Principal Display Panel
Bioelements
Breakout control
Emergency Blemish Lotion with Benzoyl Peroxide
29 mL/ 1 Fl. Oz.
Image Of Primary Artwork (Primary)
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