TARGETED ACNE SPOT TREATMENT (BENZOYL PEROXIDE 2.5%) LOTION [CVS]

TARGETED ACNE SPOT TREATMENT (BENZOYL PEROXIDE 2.5%) LOTION [CVS]
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NDC 69842-888-01
Set ID 14f6d52b-bd18-4fac-ba36-a117f4db414b
Category HUMAN OTC DRUG LABEL
Packager CVS
Generic Name
Product Class
Product Number
Application Number PART333D
  • 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

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    TARGETED ACNE SPOT TREATMENT 
    benzoyl peroxide 2.5% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-888
    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:69842-888-011 in 1 CARTON07/01/2018
    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 finalpart333D07/01/2018
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-888) , label(69842-888)

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