Label: BEVOLINE- benzoyl peroxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 25, 2016

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

  • STATEMENT OF IDENTITY

    Bevoline
    by Skin Divine

    Acne Treatment Serum

    Removes oil and impurities

    while maintaining pH-Balance

    FDA approved Bevoline is a cutting edge medicine that has transformed the acne treatment process. It goes on as a serum and dries like a mask, leaving your skin feeling silky smooth.

    • For All Skin Types
    • Does Not Dry Skin
    • Can Be Worn Under Makeup
    • Allergy Tested
    • Fragrance Free
    • Cruelty Free

    Our pH balanced formula is designed to fight:

    • Acne
    • Bacne
    • Light Acne Scarring

  • ACTIVE INGREDIENT

    Active Ingredients
    Benzoyl Peroxide 2.5%

  • WARNINGS

    Warnings

    For external use only

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or a pharmacist before use if you are using other topical acne medications at the
    same time or immediately following use of this product.

  • WHEN USING

    When using this product ● 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 by redness, burning, itching, peeling, or
    possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

  • STOP USE

    Stop use and ask a doctor if irritation becomes severe.

  • INSTRUCTIONS FOR USE

    Directions
    ● Shake well before use
    ● Clean the skin thoroughly before applying this product
    ● Cover the entire affected area with a thin layer once a day preferably at bedtime
    ● If bothersome dryness or peeling occurs, reduce application to every
    other day or as directed by a doctor
    ● Rinse thoroughly when you wake up or after a minimum four-hour drying time

  • INACTIVE INGREDIENT

    Inactive Ingredients purified water, aloe vera leaf, sodium PCA, glycerin, magnesium hydroxide, disodium EDTA, propylene glycol, anhydrous citric acid, xanthan gum.

  • DO NOT USE

    Do not use this medication if you ♦ have very sensitive skin ♦ are sensitive to benzoyl peroxide.

  • INDICATIONS & USAGE

    Uses ♦ treats acne ♦ clears acne blemishes ♦ helps prevent development of new acne blemishes

  • DOSAGE & ADMINISTRATION

    Cover the entire affected area with a thin layer once a day preferably at bedtime.

  • PURPOSE

    Acne treatment

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    Bevoline Layout

  • INGREDIENTS AND APPEARANCE
    BEVOLINE 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70013-302
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DISODIUM HEDTA (UNII: KME849MC7A)  
    MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70013-302-121 in 1 BOX02/22/2016
    1NDC:70013-302-0260 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    2NDC:70013-302-131 in 1 BOX02/22/2016
    2NDC:70013-302-03100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D02/22/2016
    Labeler - Skin Divine Inc. (079681954)
    Establishment
    NameAddressID/FEIBusiness Operations
    Skin Divine Inc.079681954manufacture(70013-302)