BREAKOUT CONTROL BIOELEMENTS- benzoyl peroxide cream

Breakout Control by

Drug Labeling and Warnings

Breakout Control by is a Otc medication manufactured, distributed, or labeled by Bioelements, Inc., Cosmetic Enterprises Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient Purpose

Benzoyl Peroxide 5% Acne treatment

Uses

For the treatment of acne

Helps prevent new acne blemishes

Keep out of reach of children. If swallowed get medical help or contact  Poison Control Center right away

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

Are sensitive to benzoyl peroxide

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

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.

PRINCIPAL DISPLAY PANEL

Bioelements

Breakout control

5% benzoyl peroxide acne treatment

invisibly spot treats to clear acne breakouts

29 mL/ 1 Fl. Oz.

INGREDIENTS AND APPEARANCE

BREAKOUT CONTROL  BIOELEMENTS
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49825-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
FYTIC ACID (UNII: 7IGF0S7R8I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49825-129-02	1 in 1 CARTON	06/14/2013
1	NDC: 49825-129-01	29 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	06/14/2013

Labeler - Bioelements, Inc. (174813923)

Registrant - Bioelements, Inc. (174813923)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Enterprises Ltd		017701475	manufacture(49825-129)