FDA Label for Breakout Control Bioelements

View Indications, Usage & Precautions

Breakout Control Bioelements Product Label

The following document was submitted to the FDA by the labeler of this product Bioelements, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient Purpose

Benzoyl Peroxide 5% Acne treatment


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  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 peroxide


Dosage & 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.


Package Label.Principal Display Panel



Bioelements

Breakout control

5% benzoyl peroxide acne treatment

invisibly spot treats to clear acne breakouts

29 mL/ 1 Fl. Oz.


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