Label: KLEER-PLEX TARGETED ACNE PEN- salicylic acid gel

  • 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 December 13, 2022

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  • Drug Facts

    Acne Treatment Gel

  • Active Ingredients

    Salicylic Acid, 2%

  • Purpose

    Acne Treatment

  • Use

    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

    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

    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

    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

  • PRINCIPAL DISPLAY PANEL

    Box

  • INGREDIENTS AND APPEARANCE
    KLEER-PLEX TARGETED ACNE PEN 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem 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
    BRUCINE SULFATE (UNII: KY7O12XPOQ)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37945-894-051 in 1 BOX10/22/201409/01/2021
    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
    Labeler - Bio-Medical & Pharmaceutical Manufacturing Corporation (072186356)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bio-Medical & Pharmaceutical Manufacturing Corporation072186356manufacture(37945-894)
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