Bioelements Breakout Control

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 2.5mL in 100mL
Labeler: Bioelements, Inc.
NDC Code: 49825-116

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.

Breakout Control

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 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 another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
Avoid unnecessary sun exposure and use a sunscreen
Avoid contact 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 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 affected area with a thin layer one to three times daily
Because of 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. I f 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 Barbadensis (Aloe) Leaf Juice Powder, Phytic Acid, Phenoxyethanol, Potassium Sorbate, Disodium EDTA.








Bioelements

Breakout Control

Emergency Blemish Lotion with Benzoyl Peroxide


29 mL/ 1 Fl. Oz.












BIOELEMENTS  BREAKOUT CONTROL
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: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
WATER 
PENTYLENE GLYCOL 
SQUALENE 
POLYSORBATE 60 
FYTIC ACID 
PHENOXYETHANOL 
POTASSIUM SORBATE 
EDETATE DISODIUM 
Packaging
#Item CodePackage Description
1NDC:49825-116-021 BOTTLE (BOTTLE) in 1 BOX
1NDC:49825-116-0129 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D01/01/2009
Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
NameAddressID/FEIOperations
Chemolee Lab Corporation809982754manufacture
Establishment
NameAddressID/FEIOperations
Cosmetic Enterprise017701475manufacture

Revised: 04/2012
 
Bioelements, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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