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Name:Bioelementsbreakout Control
Manufacturer:Bioelements, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Breakout Control

BIOELEMENTS BREAKOUT CONTROL - benzoyl peroxide cream 
Bioelements, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Breakout Control


Active Ingredients                        Purpose   

Benzoyl Peroxide  2.5%          Acne Treatment

-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.

-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.


-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 Type HUMAN OTC DRUG Item Code (Source) NDC:49825-116
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 2.5 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES  
BUTYLENE GLYCOL  
GLYCERYL MONOSTEARATE  
STEARIC ACID  
DIETHYLHEXYL ADIPATE  
SORBITOL  
POLYSORBATE 80  
SODIUM HYDROXIDE  
CAPRYLYL GLYCOL  
EDETATE SODIUM  
PHENOXYETHANOL  
METHYLISOTHIAZOLINONE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49825-116-02 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE (49825-116-01)
1 NDC:49825-116-01 29 mL in 1 BOTTLE This package is contained within the BOX (49825-116-02)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 01/01/2009

Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
Name Address ID/FEI Operations
Chemolee Lab Corporation 809982754 manufacture

Revised: 03/2011 Bioelements, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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