Label: SKINPHARMACY ADVANCED ACNE THERAPY KIT- salicylic acid, benzoyl peroxide kit

  • 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 March 14, 2017

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  • SPL UNCLASSIFIED SECTION

    4 FL OZ (118 mL)

    Drug Facts

  • Active Ingredient

    2% Salicylic Acid

  • Purpose

    Acne Treatment

  • Use

    • For the management of acne
  • Warnings

    For external use only

    Ask a doctor or pharmacist before use if you are

    Using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    When using this product

    • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • When using this product avoid contact with eyes. If this occurs, immediately flush with water.

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact Poison Control Center right away.

  • Directions

    • Use morning and night.
    • Apply a dime sized amount to damp skin and gently massage for 1 to 2 minutes.
    • Rinse thoroughly with warm water.
    • Pat dry.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • If going outside use sunscreen
  • Inactive ingredients

    Water, Sodium C14-16 Olefin Sulfonate, Peg-8, Cocamidopropyl Betaine, Xanthan Gum, Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer, DMDM Hydantoin, Disodium EDTA, Tocopheryl Acetate, Hamamelis Virginiana (Witch Hazel) Water, Butylene Glycol, Sodium Benzotriazolyl Butylphenol Sulfonate, Calendula Officinalis Flower Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Phenoxyethanol, Yellow 5, Red 40, Fragrance.

  • SPL UNCLASSIFIED SECTION

    ACTIVE CLEARING LOTION with Microsponge® Technology

    0.75 FL OZ (22 mL)

    Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 2.5%

  • Purpose

    Acne Treatment

  • Use

    • for the management of acne
  • Warnings

    For external use only

    Do not use this medication if you

    • Have very sensitive skin
    • Are sensitive to benzoyl peroxide

    When using this product

    • Avoid unnecessary sun exposure and use a sunscreen after using this product.
    • Avoid contact with lips, eyes, or mouth.
    • If product gets into eyes rinse thoroughly with water.
    • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling. Irritation may be reduced by using the product less frequently or in lower concentration.
    • Avoid contact with hair and dyed fabrics, which may be bleached by this product.

    Stop use and ask a doctor if irritation becomes severe.

    Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean skin thoroughly before applying this product.
    • Apply a thin layer to affected area one to two times per day.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three time 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.
  • Inactive ingredients

    Water, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Cetyl Alcohol, Sorbitol, Glyceryl Dilaurate, Stearyl Alcohol, Magnesium Aluminum Silicate, Sodium Citrate, Silica, Sodium Lauryl Sulfate, Citric Acid, Methylparaben, Xanthan Gum, Propylparaben.

  • SPL UNCLASSIFIED SECTION

    SPOT TREATMENT with Microsponge® Technology

    0.4 FL OZ (12 mL)

    Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 5%

  • Purpose

    Acne Treatment

  • Use

    • for the management of acne
  • Warnings

    For external use only

    Do not use this medication if you

    • Have very sensitive skin
    • Are sensitive to benzoyl peroxide

    When using this product

    • Avoid unnecessary sun exposure and use a sunscreen after using this product.
    • Avoid contact with lips, eyes, or mouth.
    • If product gets into eyes rinse thoroughly with water.
    • Skin irritation may occur, characterized by redness, burning, itching, peeling, or possible swelling. Irritation may be reduced by using the product less frequently or in lower concentration.
    • Avoid contact with hair and dyed fabrics, which may be bleached by this product.

    Stop use and ask a doctor if irritation becomes severe.

    Keep out of reach of children. Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean skin thoroughly before applying this product.
    • Cover the entire affected area with a thin layer one to three times daily.
    • If going outside apply sunscreen after using this product and consult a physician. Keep tightly closed and avoid storing at extreme temperatures (below 40°F and above 100°F).
  • Inactive ingredients

    Water, Glycerin, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sorbitol, Cetyl Alcohol, Glyceryl Dilaurate, Stearyl Alcohol, Magnesium Aluminum Silicate, Sodium Citrate, Silica, Sodium Lauryl Sulfate, Citric Acid, Methylparaben, Xanthan Gum, Propylparaben.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI 02895

    © 2014 CVS/pharmacy

    CVS.com® 1-800-SHOP CVS

    Made in the U.S.A. of U.S. and imported components

    V-31490

    CVS® Quality

    Money Back Guarantee

    #975032

    M050779CP

  • Principal Display Panel - Carton Label

    SKIN+PHARMACY

    ADVANCED
    ACNE THERAPY KIT

    $35 VALUE

    $19.99

    BONUS:

    Includes 2 Gentle Facial
    Cleansing Sponges

    exclusively at
    CVS/pharmacy

    ONE MONTH SUPPLY

    Actual Size Product Shown

    Principal Display Panel - Carton Label
  • Principal Display Panel - Clarifying Daily Cleanser Tube Label

    SKIN+PHARMACY

    ADVANCED
    ACNE
    THERAPY

    CLARIFYING
    DAILY CLEANSER
    with Polytrap    ® Technology

    Maximum Strength

    2% Salicylic Acid

    • removes excess skin oils
    • unclogs pores
    • oil-free formula

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    4 FL OZ (118 mL)

    Principal Display Panel - Clarifying Daily Cleanser Tube Label
  • Principal Display Panel - Active Clearing Lotion Tube Label

    SKIN+PHARMACY

    ADVANCED
    ACNE
    THERAPY

    ACTIVE CLEARING LOTION
    with Microsponge    ® Technology

    • clinically proven to kill acne-causing bacteria
    • clinically proven to effectively reduce inflammatory lesions
    • soothing, oil-free formula
    • unclogs pores
    • fragrance free

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    0.75 FL OZ (22 mL)

    Principal Display Panel - Active Clearing Lotion Tube Label
  • Principal Display Panel - Spot Treatment Tube Label

    SKIN+PHARMACY

    ADVANCED
    ACNE
    THERAPY

    SPOT TREATMENT
    with Microsponge    ® Technology

    5% Benzoyl Peroxide

    • clinically proven to effectively reduce inflammatory lesions
    • effectively kills acne-causing bacteria
    • helps reduce irritation
    • fragrance free

    DERMATOLOGIST TESTED

    exclusively at
    CVS/pharmacy

    0.4 FL OZ (12 mL)

    Principal Display Panel - Spot Treatment Tube Label
  • INGREDIENTS AND APPEARANCE
    SKINPHARMACY ADVANCED ACNE THERAPY KIT 
    salicylic acid, benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-082
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-082-011 in 1 CARTON; Type 0: Not a Combination Product10/01/2014
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 118 mL
    Part 21 TUBE 22 mL
    Part 31 TUBE 12 mL
    Part 1 of 3
    SKINPHARMACY ADVANCED ACNE THERAPY   CLARIFYING DAILY CLEANSER
    salicylic acid liquid
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    salicylic acid (UNII: O414PZ4LPZ) (salicylic acid - UNII:O414PZ4LPZ) salicylic acid20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    sodium C14-16 olefin sulfonate (UNII: O9W3D3YF5U)  
    polyethylene glycol 4000 (UNII: 4R4HFI6D95)  
    cocamidopropyl betaine (UNII: 5OCF3O11KX)  
    Xanthan gum (UNII: TTV12P4NEE)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    edetate disodium (UNII: 7FLD91C86K)  
    .alpha.-tocopherol acetate, DL- (UNII: WR1WPI7EW8)  
    Hamamelis virginiana flower water (UNII: 222MYC9QUV)  
    Butylene glycol (UNII: 3XUS85K0RA)  
    Calendula Officinalis flower (UNII: P0M7O4Y7YD)  
    licorice (UNII: 61ZBX54883)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    Lauryl Methacrylate/Glycol Dimethacrylate Crosspolymer (UNII: EX0F4CZ66H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2014
    Part 2 of 3
    SKINPHARMACY ADVANCED ACNE THERAPY   ACTIVE CLEARING
    benzoyl peroxide lotion
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    benzoyl peroxide (UNII: W9WZN9A0GM) (benzoyl peroxide - UNII:W9WZN9A0GM) benzoyl peroxide25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)  
    cetyl alcohol (UNII: 936JST6JCN)  
    sorbitol (UNII: 506T60A25R)  
    glyceryl dilaurate (UNII: MFL3ZIE8SK)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    methylparaben (UNII: A2I8C7HI9T)  
    xanthan gum (UNII: TTV12P4NEE)  
    propylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    122 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2014
    Part 3 of 3
    SKINPHARMACY ADVANCED ACNE THERAPY   SPOT TREATMENT
    benzoyl peroxide lotion
    Product Information
    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
    water (UNII: 059QF0KO0R)  
    glycerin (UNII: PDC6A3C0OX)  
    methyl methacrylate/glycol dimethacrylate crosspolymer (UNII: EG97988M5Q)  
    cetyl alcohol (UNII: 936JST6JCN)  
    sorbitol (UNII: 506T60A25R)  
    glyceryl dilaurate (UNII: MFL3ZIE8SK)  
    stearyl alcohol (UNII: 2KR89I4H1Y)  
    magnesium aluminum silicate (UNII: 6M3P64V0NC)  
    sodium citrate (UNII: 1Q73Q2JULR)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sodium lauryl sulfate (UNII: 368GB5141J)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    methylparaben (UNII: A2I8C7HI9T)  
    xanthan gum (UNII: TTV12P4NEE)  
    propylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2014
    Labeler - CVS Health (062312574)
    Registrant - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Health & Beauty Solutions, Inc. DBA872684803ANALYSIS(69842-082) , MANUFACTURE(69842-082) , LABEL(69842-082) , PACK(69842-082)
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