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Breakout Control

Bioelements, Inc.
Bioelements, Inc.

Breakout Control Acne treatment




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredient                 Purpose

Benzoyl Peroxide 5%          Acne treatment

Purpose

Uses

For the treatment of acne

Helps prevent new acne blemishes

Keep out of reach of children. If swallowed get medical help or contact a poison control center right away

Uses

Stop use and ask a doctor if:

irritation becomes severe

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


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 ingredients






Breakout Control

Bioelements

Breakout control

Emergency Blemish Lotion with Benzoyl Peroxide

29 mL/ 1 Fl. Oz.





Breakout Control



Breakout Control

Benzoyl Peroxide LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49825-124
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 5 mL

Inactive Ingredients

Ingredient Name Strength
water
PENTYLENE GLYCOL
SQUALENE
POLYSORBATE 60
Aloe Vera Leaf
fytic acid
PHENOXYETHANOL
POTASSIUM SORBATE
EDETATE DISODIUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49825-124-01 29 in 1 JAR
2 NDC:49825-124-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2012-03-26


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Be sure to consult your doctor before taking any medication!
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