Label: ACNE RELIEF MAXIMUM STRENGTH SPOT GEL- salicylic acid acne treatment 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 February 10, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient
    Salicylic Acid 2.0%

  • PURPOSE

    Purpose
    Acne Treatment

  • INDICATIONS & USAGE

    Use■ For the treatment of acne.

  • WARNINGS

    Warnings■ For external use only. ■
    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. ■ Keep out of reach of children.
    If swallowed, get medical help or contact
    a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    Directions ■ Clean the skin thoroughly
    before applying this product. ■ Cover the
    entire affected area with a thin layer one
    to three times daily. ■ Because excessive
    drying of the skin may occur, start with one
    application daily, then gradually increase
    to two or three 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. ■ 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 INGREDIENT

    Inactive Ingredients Water/Aqua/Eau,
    SD Alcohol 40-B, Propanediol, Hamamelis
    Virginiana (Witch Hazel) Water, Glycerin,
    Sucrose, Citrulline, Hydroxyethylcellulose,
    Urea, Panthenol, Lactic Acid, Melaleuca
    Alternifolia (Tea Tree) Leaf Oil, Sodium Hydroxide,
    Tetrasodium Glutamate Diacetate,
    Succinic Acid, Alcohol, Polysorbate 20

  • QUESTIONS

    Questions1-888-823-7837

  • Product Package

    ACNE RELIEF
    Maximum Strength Spot Gel
    Minimizes blemishes & helps prevent
    future breakouts

    Perricone MD

    ACNE RELIEF

    Maximum
    Strength
    Spot Gel

    Salicylic Acid
    Acne Treatment

    90 DAY SUPPLY

    Lactic & Succinic Acids,
    Citrulline, Tea Tree Oil

    ℮ Net Wt 0.5oz / 14.1 g

    KEY
    INGREDIENTS

    Lactic & Succinic
    Acids: Attack Acne-
    Causing Bacteria
    These short-chain fatty
    acids help quickly shrink
    blemishes by working
    alongside salicylic acid
    to attack acne-causing
    bacteria for a healthier
    skin microbiome. They
    also provide gentle yet
    effective exfoliation for
    smoother, more even-looking
    skin.

    Citrulline: Fight Irritation
    & Visibly Reduce
    Redness First discovered
    in watermelon,
    this alpha-amino acid
    visibly calms skin for
    a clearer, more even-looking
    complexion.
    Nourishing & soothing,
    it is an ideal way to
    counteract the irritating
    effects of antiacne
    ingredients.

    Tea Tree Oil: Cleanse,
    Clarify & Soothe This
    powerful essential oil
    helps visibly reduce
    redness & calm skin.
    It easily penetrates
    skin’s surface, features
    a light, refreshing scent
    similar to eucalyptus
    & has been used for
    centuries in traditional
    Australian medicine.

    This maximum strength invisible gel works
    overtime to reduce blemishes & prevent
    future breakouts by killing acne-causing
    bacteria, unclogging pores & absorbing
    excess oil without over-drying.

    Dist. By: NV Perricone LLC, San Francisco,
    CA 94111. Made in USA of foreign and
    domestic components. 651199

    1 888 823 7837 perriconemd.com

    Expiration &
    Lot Code area

    Outer Box

    Acne Max 14.1g Box

    Tube

    Acne Max 14.1g

    rege

  • INGREDIENTS AND APPEARANCE
    ACNE RELIEF MAXIMUM STRENGTH SPOT GEL 
    salicylic acid acne treatment gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUCROSE (UNII: C151H8M554)  
    CITRULLINE (UNII: 29VT07BGDA)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    UREA (UNII: 8W8T17847W)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SUCCINIC ACID (UNII: AB6MNQ6J6L)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45634-100-011 in 1 PACKAGE08/01/2019
    114.1 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D08/01/2019
    Labeler - NV Perricone LLC (054414243)
    Registrant - NV Perricone LLC (054414243)