Label: NEUTRACURE RESTORE- benzoyl peroxide cream

  • 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 16, 2017

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

  • Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 5%

    Purpose

    Acne Medication

  • Uses

    • fot the treatment of acne
    • use to prevent new pimples from forming
  • Warnings

    For external use only

    Do not use if

    if you have very sensitive skin or are sensitive to benzoyl peroxide.

    When using this product

    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with the eyes, lips and mouth
    • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
    • with other topical acne medications, at the same time ot immediately following use of this product. Increased dryness or imitation may occur. If this occurs, only one medication should be used unless directed by a doctor.
    • skin imitation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate skin imitation. Mild imitation may be reduced by using the product less frequently or in a lower concentration.

    Stop use and ask a doctor

    if skin irritation becomes severe

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • cleanse the skin thoroughly before applying medication
    • cover the entire affected area with a thin layer one to three times a day
    • 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 use a sunscreen. Allow Acne Treatment Cream to dry, then follow directions in sunscreen labeling . If sensitivity develops, discontinue use of both products and ask a doctor
  • Other Information

    • keep tightly closed
    • keep away from heat
  • Inactive ingredients:

    ALLANTOIN, ALOE BARBADENSIS LEAF (ALOE VERA GEL) JUICE, BENZYL ALCOHOL, BETULA ALBA (BIRCH) EXTRACT, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CARBOMER, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS MEDICA LIMONUM (LEMON) OIL, DMDM HYDANTOIN,
    GLYCERIN, HAMAMELIS VIRGINIANA (WITCH HAZEL), IODOPROPYNYL BUTYLCARBAMATE, MELALEUCA ALTERNIFOLIA (TEA TREE) OIL, MENTHOL,
    METHYLISOTHIAZOLINONE, PARFUM (FRAGRANCE), POLYSORBATE-20, SACCHARUM OFFICINALIS (SUGAR) CANE EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, SALVIA OFFICINALIS (SAGE) EXTRACT, SODIUM CITRATE, SODIUM HYALURONATE (HYALURONIC ACID), SODIUM HYDROXIDE,
    TRIETHANOLAMINE, VACCINIUM MYRTILLUS (BILBERRY) EXTRACT, XANTHAN GUM

  • Product Label

    Box1

  • INGREDIENTS AND APPEARANCE
    NEUTRACURE RESTORE 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69748-641
    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
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69748-641-0159 mL in 1 JAR; Type 0: Not a Combination Product02/07/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/10/2015
    Labeler - Neutracure (079725043)