Label: ACNE RELIEF RETINOL TREATMENT AND MOISTURIZER- salicylic acid acne treatment lotion

  • Category: HUMAN OTC DRUG LABEL

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

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient
    Salicylic Acid 0.5%

  • 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
    ■ Shake well. Apply a thin, even layer to skin in the evening.
      For best results, use after cleansing with ACNE RELIEF
      Gentle & Soothing Cleanser.
    ■ 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,
    Glycerin, Dicaprylyl Ether, Niacinamide, Citrulline, Arginine, Methyl
    Gluceth-20, Cetearyl Alcohol, Carbomer, Xanthan Gum, Tocopheryl
    Acetate, Retinol, Citric Acid, Sodium Hydroxide, Disodium
    EDTA, PEG-20 Methyl Glucose Sesquistearate, PEG-100 Stearate,
    Glyceryl Stearate, Methyl Glucose Sesquistearate, Polysorbate
    20, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

  • QUESTIONS

    Questions 1-888-823-7837

  • Product Package

    ACNE RELIEF

    Retinol Treatment
    & Moisturizer

    Controls excess oil & fights
    blemishes overnight

    STEP 2
    NIGHT

    Perricone MD

    ACNE RELIEF
    Retinol Treatment
    & Moisturizer

    Salicylic Acid
    Acne Treatment

    90 DAY SUPPLY

    Niacinamide, Citrulline,
    Retinol

    ℮ 59 mL / 2 fl oz

    KEY INGREDIENTS
    Niacinamide: Gentle Skin-
    Clearing Multi-Tasker Also
    known as vitamin B3 & found in
    foods such as tomatoes, this skin-
    clearing powerhouse helps to
    gently & visibly erase imperfections,
    unclog oily pores & minimize
    redness & uneven skin tone that
    can be left behind after breakouts
    by improving skin’s moisture
    barrier. B3 is a powerful antioxidant
    & an essential nutrient
    that plays a key role in many of
    the body’s basic functions.

    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 anti-acne ingredients.

    Retinol: Exfoliate for Clearer
    Skin & Accelerated Rejuvenation
    This ultra-powerful, non-prescription
    vitamin A derivative helps
    prevent breakouts by unclogging
    pores & accelerating surface skin
    exfoliation & renewal. Unique
    slow-release carrier system helps
    preserve this unstable ingredient
    & calm skin.

    Expiration &
    Lot Code area

    Perricone MD ACNE RELIEF
    Prebiotic Acne Therapy is a
    simple, comprehensive system
    that works with your surface
    skin’s natural microbiome to
    safely, gently & effectively treat
    & prevent the most troublesome
    acne, while restoring &
    maintaining a healthy skin
    balance, for clearer, blemish-
    free skin. This powerful 2-step
    regimen is clinically proven to
    be non-irritating & will not
    strip or over-dry skin.

    The Retinol Treatment & Moisturizer
    is Step 2 in your night
    regimen, after cleansing. The
    lightweight yet nourishing
    formula absorbs instantly to
    control excess oil & helps to
    heal blemishes while you sleep
    without over-drying the skin.
    The powerful combination of
    retinol, citrulline & niacinamide
    helps to accelerate surface
    skin exfoliation & renewal, visibly
    calm skin & reduce redness,
    while gently & visibly erasing
    imperfections overnight.

    Dist. By: NV Perricone LLC, San Francisco,
    CA 94111. Made in USA of foreign and
    domestic components. 651197

    1 888 823 7837
    perriconemd.com

    Outer Box

    Acne  49mL box

    Bottle

    Acne  49mL btl

    rege

  • INGREDIENTS AND APPEARANCE
    ACNE RELIEF RETINOL TREATMENT AND MOISTURIZER 
    salicylic acid acne treatment lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.295 g  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    CITRULLINE (UNII: 29VT07BGDA)  
    ARGININE (UNII: 94ZLA3W45F)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    RETINOL (UNII: G2SH0XKK91)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45634-101-011 in 1 PACKAGE08/01/2019
    159 mL in 1 BOTTLE, DROPPER; 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)