Label: KLEER-PLEX ADVANCED ACNE CARE SYSTEM- salicylic acid 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 November 3, 2014

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  • THIS SYSTEM CONTAINS:

    (1) Foaming Acne Clarifier

           NDC 37945-870-40

    (1) Pore Purifier & Toner

    (1) Penetrating Acne Gel

           NDC 37945-874-11

    (1) Targeted Acne Pen

           NDC 37945-894-05

  • DRUG FACTS

    Acne Treatment Wash and Acne Treatment Gel

  • Active Ingredient

    Salicylic Acid, 2%

  • Purpose

    Acne Treatment

  • Uses

    • For the management of acne.
    • Clears up most acne pimples, blackheads, and whiteheads and allows skin to heal.
    • Penetrates pores to eliminate most acne blemishes.
    • Helps prevent new acne pimples.
  • Warnings

    For external use only.

  • When using this product

    • Skin irritation and dryness is 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.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Directions

    Acne Treatment Wash

    • At least once each day, dispense a small amount of cleanser onto an exfoliating pad or cloth.
    • Add a small amount of water and work into a lather on the face using small circular motions avoiding the eyes.
    • Repeat after perspiration or makeup use.
    • If dryness occurs, reduce frequency to once each day.

    Acne Treatment Gel

    • Each night, dispense a small amount of gel onto the fingertips.
    • Spread gel sparingly on the face and other affected areas using small circular motions avoiding the eyes.
    • Repeat after perspiration or makeup use.
    • If dryness occurs, reduce frequency to once each day.
  • Sensitivity Test for a New User - Acne Treatment Gel

    • Apply product sparingly to one or two small affected areas during the first 3 days.
    • If no discomfort occurs, follow the directions stated above.
  • Inactive Ingredients

    Acne Treatment Wash

    Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Propylene Glycol, Hydroxypropyl Bis-Hydroxyethyldimonium Chloride, Triethanolamine, Hydroxypropylmethylcellulose, Magnesium Sulfate, 3-iodo-2-propynylbutylcarbamate, Diazolidinyl Urea, Peppermint Oil, Methylparaben, Propylparaben.

    Acne Treatment Gel

    Purified Water, Alcohol, Glycerin, Xanthan Gum, Polysorbate 20, Peppermint Oil, (.Alpha.-Tocopherol Acetate), Wheat Germ Oil, Glycolic Acid, Tert-Butyl Alcohol, Brucine Sulfate.

  • Questions or Comments

    281-835-8051

    M-F 8 AM to 5 PM

  • Kleer-Plex Advanced Acne SystemPrincipal Display PanelNDC# 37945-876-91

    KleerPlexFront.jpgFront KleerPlexBack.jpgBack

  • INGREDIENTS AND APPEARANCE
    KLEER-PLEX ADVANCED ACNE CARE SYSTEM 
    salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37945-876
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37945-876-911 in 1 KIT; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PUMP 118 mL
    Part 21 BOTTLE 236.558 mL
    Part 31 BOTTLE 30 mL
    Part 41 APPLICATOR 15 mL
    Part 1 of 4
    KLEER-PLEX FOAMING ACNE CLARIFIER 
    salicylic acid liquid
    Product Information
    Item Code (Source)NDC:37945-870
    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)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDE (UNII: 1EO3O1X7HG)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM SULFATE (UNII: DE08037SAB)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37945-870-401 in 1 BOX
    1118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/03/2014
    Part 2 of 4
    KLEER-PLEX PORE PURIFIER AND TONER 
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWITCH HAZEL (UNII: 101I4J0U34)  
    INGRHORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    INGRWHITE OAK BARK (UNII: 93LP7Y8EGT)  
    INGRECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX)  
    INGRCHASTE TREE (UNII: 433OSF3U8A)  
    INGRGOLDENSEAL (UNII: ZW3Z11D0JV)  
    INGRALCOHOL (UNII: 3K9958V90M)  
    INGRLAVENDER OIL (UNII: ZBP1YXW0H8)  
    INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGRETHYL LAUROYL ARGINATE HYDROCHLORIDE (UNII: XPD6ZY79TB)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRLEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGR10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)  
    INGRSEBACIC ACID (UNII: 97AN39ICTC)  
    INGR1,10-DECANEDIOL (UNII: 5I577UDK52)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1236.558 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 3 of 4
    KLEER-PLEX PENETRATING ACNE 
    salicylic acid gel
    Product Information
    Item Code (Source)NDC:37945-874
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    BRUCINE SULFATE (UNII: KY7O12XPOQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37945-874-111 in 1 BOX
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/22/2014
    Part 4 of 4
    KLEER-PLEX TARGETED ACNE PEN 
    salicylic acid gel
    Product Information
    Item Code (Source)NDC:37945-894
    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)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    BRUCINE SULFATE (UNII: KY7O12XPOQ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37945-894-051 in 1 BOX
    115 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/22/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/03/2014
    Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-876, 37945-870, 37945-874, 37945-894)
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