Label: ACNE RELIEF CALMING TREATMENT AND HYDRATOR- 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 morning.
       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, C12-15 Alkyl Lactate, PVP, Dimethicone, Polysor-
    bate 20, Citrulline, Squalane, Lactic Acid, Succinic Acid, Poly-
    acrylamide, Dimethicone/Vinyl Dimethicone Crosspolymer,
    C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Sodium Benzo-
    atr, Potassium Sorbate

  • QUESTIONS

    Questions 1-888-823-7837

  • Product Package

    ACNE RELIEF

    Calming Treatment
    & Hydrator

    Nourishes, hydrates & visibly
    reduces redness

    STEP 2
    DAY

    Perricone MD

    ACNE RELIEF

    90 DAY SUPPLY

    Lactic & Succinic Acids,
    Citrulline, Squalane

    ℮ 59 mL / 2 fl oz

    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 ex-
    foliation 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 anti-acne ingredients.

    Squalane: Hydrate & Nourish
    Found naturally in the human
    body & derived from olive oil,
    squalane hydrates without making
    skin look or feel greasy. This lightweight
    hydration is ideal for oil
    & acne-prone skin as it helps
    maintain optimal hydration without
    clogging pores or causing
    blemishes.

    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 Calming Treatment &
    Hydrator is Step 2 in your day or
    morning regimen, after cleans-
    ing, The lightweight lotion
    glides onto skin to gently kill
    acne-causing bacteria, while
    nourishing with essential hy-
    dration.  Lactic & succinic acids
    support a healthy surface skin
    microbiome for a clearer, more
    radiant complexion, while citrul-
    line & squalane fight irritation,
    nourish, hydrate, soothe & vis-
    ibly reduce redness.

    Dist. By: NV Perricone LLC, San Francisco,
    CA 94111. Made in USA of foreign and
    domestic components. 651196

    1 888 823 7837
    perriconemd.com

    Expiration &
    Lot Code area

    Outer Box

    AcneDay 59 mL Box

    Bottle

    AcneDay 59 mL Btl

    rege

  • INGREDIENTS AND APPEARANCE
    ACNE RELIEF CALMING TREATMENT AND HYDRATOR 
    salicylic acid acne treatment lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45634-102
    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)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRULLINE (UNII: 29VT07BGDA)  
    SQUALANE (UNII: GW89575KF9)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    SUCCINIC ACID (UNII: AB6MNQ6J6L)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45634-102-011 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)