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

  • NDC Code(s): 68634-067-01
  • Packager: AMCOL Health & Beauty Solutions, Inc. DBA
  • 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 October 11, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    2% Salicylic Acid

  • 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 salicylic acid

    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.

    M050775

  • Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Carton Label

    SKIN+PHARMACY

    ADVANCED
    ACNE THERAPY KIT

    DERMATOLOGIST TESTED

    BONUS:

    Includes 2 Gentle Facial

    Cleansing Sponges

    exclusively at
    CVS/pharmacy

    $35 VALUE

    $19.99

    ONE MONTH SUPPLY

    Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Carton Label
  • Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit 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 - Skin+Pharmacy Advanced Acne Therapy Kit Label
  • Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit Label

    SKIN+PHARMACY

    ADVANCED
    ACNE
    THERAPY

    ACTIVE CLEARING LOTION
    with Microsponge    ® Technology

    2.5% Benzoyl Peroxide

    • 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 - Skin+Pharmacy Advanced Acne Therapy Kit Label
  • Principal Display Panel - Skin+Pharmacy Advanced Acne Therapy Kit 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 - Skin+Pharmacy Advanced Acne Therapy Kit Label
  • INGREDIENTS AND APPEARANCE
    SKIN PHARMACY ADVANCED ACNE THERAPY KIT 
    salicylic acid, benzoyl peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68634-067
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68634-067-011 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
    SKIN PHARMACY 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 g  in 2 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
    SKIN PHARMACY 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 g  in 2 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
    SKIN PHARMACY 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 g  in 2 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 - AMCOL Health & Beauty Solutions, Inc. DBA (872684803)
    Establishment
    NameAddressID/FEIBusiness Operations
    AMCOL Household & Personal Care872684803MANUFACTURE(68634-067) , PACK(68634-067) , LABEL(68634-067) , ANALYSIS(68634-067)
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