Label: BREAKOUT CONTROL ACNE TREATMENT- benzoyl peroxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated March 27, 2012

If you are a consumer or patient please visit this version.

  • 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 a 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.



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  • PRINCIPAL DISPLAY PANEL

    Bioelements

    Breakout control

    Emergency Blemish Lotion with Benzoyl Peroxide

    29 mL/ 1 Fl. Oz.





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  • INGREDIENTS AND APPEARANCE
    BREAKOUT CONTROL  ACNE TREATMENT
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49825-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SQUALENE (UNII: 7QWM220FJH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49825-124-021 in 1 BOX
    1NDC:49825-124-0129 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D03/26/2012
    Labeler - Bioelements, Inc. (174813923)
    Registrant - Bioelements, Inc. (174813923)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Enterprises Ltd017701475manufacture