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 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.


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Bioelements

Breakout Control

Emergency Blemish Lotion with Benzoyl Peroxide


29 mL/ 1 Fl. Oz.



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BIOELEMENTS   BREAKOUT CONTROL
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SQUALENE (UNII: 7QWM220FJH)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
FYTIC ACID (UNII: 7IGF0S7R8I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49825-116-021 in 1 BOX01/01/200912/31/2014
1NDC:49825-116-0129 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/200912/31/2014
Labeler - Bioelements, Inc. (174813923)
Registrant - Bioelements, Inc. (174813923)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Enterprise017701475manufacture(49825-116)
Establishment
NameAddressID/FEIBusiness Operations
Chemolee Lab Corporation809982754manufacture(49825-116)

Revised: 3/2018
 
Bioelements, Inc.