BIOELEMENTS BREAKOUT CONTROL - benzoyl peroxide cream 
Bioelements, Inc.

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Breakout Control

Active Ingredients                  Purpose  

Benzoyl Peroxide  2.5%        Acne Treatment

Warnings:

-For external use only

-When using this product: Avoid unnecessary sun exposure and use a sunscreen

-Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

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

Uses:

-For the treatment of acne

-Helps prevent new acne blemishes


Directions

-Cleanse skin thoroughly before applying.

-Cover the affected area with a thin layer 1 to 3 times a day. Because excessive drying of the skin many occur, start with 1 application daily, then gradually 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, use a sunscreen. Allow Breakout Control to dry, then follow directions on the sunscreen labeling. If sensitivity develops, discontinue use of both products and consult a doctor.

Inactive Ingredients: Water (Aqua) (Eau), Caprylic/Capric Triglyceride, Butylene Glycol, Glyceryl Stearate SE, Stearic Acid, Dioctyl Adipate, Sorbitol, Polysorbate 80, Carbomer, Sodium Hydroxide, Caprylyl Glycol, Tetrasodium EDTA, Phenoxyethanol, Methylisothiazolinone

image of carton

Bioelements

Breakout Control

29 mL/ 1 Fl. Oz.

image of front label


BIOELEMENTS  BREAKOUT CONTROL
benzoyl peroxide   cream
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)49825-116
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE2.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
149825-116-021 BOTTLE In 1 BOXcontains a BOTTLE (49825-116-01)
149825-116-0129 mL In 1 BOTTLEThis package is contained within the BOX (49825-116-02)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33301/01/2009

Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
NameAddressID/FEIOperations
Bioelements, Inc. 174813923manufacture
Revised: 05/2010Bioelements, Inc.