Label: SPOT ACNE TREATMENT- benzoyl peroxide 2.5% 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 May 4, 2018

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

  • ACTIVE INGREDIENT

    Active ingredient                                             Purpose
    Benzoyl peroxide 2.5% ................  ................. Acne Treatment

  • PURPOSE

  • INDICATIONS & USAGE

    Uses Helps prevent new acne blemishes.

  • WARNINGS

    Warnings
    For external use only.
    Do not use if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
    Stop use and ask a doctor if irritation becomes severe.
    When using this product:
    ■ avoid unnecessary sun exposure and use a sunscreen
    ■ using other topical acne drugs at the same time or right after use may increase dryness or irritation of skin.
    If this occurs, only one drug should be used
    ■ 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
    ■ keep away from eyes, lips and mouth
    ■ avoid contact with hair and dyed fabrics, which may be bleached by this product

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions
    Cleanse skin thoroughly before applying. Cover entire affected area with a thin layer 1 to 3 times daily. Start
    with one application daily, because excessive drying may occur. Then gradually increase to 2 or 3 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 medication to dry before application of
    sunscreen. If irritation or sensitivity develops, stop use of both products and ask a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Bentonite, Caprylic/Capric Triglyceride, Cetyl Dimethicone, Citric Acid, Disodium EDTA, Emulsifying Wax NF,
    Ethylhexylglycerin, Glycerin, Glyceryl Laurate, Magnesium Aluminum Silicate, Phenoxyethanol, Polysorbate 20,
    Sodium Citrate, Water, Xanthan Gum.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SPOT ACNE TREATMENT 
    benzoyl peroxide 2.5% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7784
    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 g
    Inactive Ingredients
    Ingredient NameStrength
    Bentonite (UNII: A3N5ZCN45C)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Glyceryl Laurate (UNII: Y98611C087)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    Water (UNII: 059QF0KO0R)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7784-011 in 1 CARTON10/23/2017
    121 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/23/2017
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(0363-7784) , label(0363-7784)