Label: NEUTRALYZE CLEARING SERUM- 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 January 25, 2023

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  • Active Ingredient

    Salicylic acid 2%

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • 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 unless directed by a doctor. Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Avoid unnecessary sun exposure and use a sunscreen of SPF15 or higher.

    Do not use if you have very sensitive skin or are sensitive to salicylic acid.

    Stop use and ask a doctor if irritation becomes severe.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    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 these directions: cover the entire affected area with a thin layer one to three times daily. Do not rinse off. Because excessive drying or skin irritation may occur, start with one application daily, then gradually increase to two to three times daily if needed or directed by a doctor. If bothersome dryness, peeling or irritation occurs, reduce application to once a day or every other day.

  • Inactive Ingredients:

    WATER, ALCOHOL, DIMETHICONE, BETAINE, 1,2-HEXANEDIOL, MANDELIC ACID, POLYACRYLATE CROSSROLYMER-6,DEHYDROXANTHAN GUM, PHENOXYETHANOL, AMMONIA, T-BUTYL ALCOHOL, DENATONIUM BENZOATE, BLUE 1 (CL 42090)

  • Principal Display Panel – Bottle Label.

    neutralyze®

    NEUTRALYZE CLEARING SERUM

    SKIN REPAIRING

    ACNE TREATMENT GEL

    STEP 2 – REPAIR

    CLEARS ACNE, FADES DARK SPOTS
    & CORRECTS UNEVEN SKIN TONE

    CONTROLS OIL, UNCLOGS &
    REDUCES THE SIZE OF PORES

    1.52 FL. OZ./45 mL

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    NEUTRALYZE CLEARING SERUM 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57524-015
    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)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Betaine (UNII: 3SCV180C9W)  
    1,2-hexanediol (UNII: TR046Y3K1G)  
    Mandelic Acid (UNII: NH496X0UJX)  
    Ammonium Acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) (UNII: Q7UI015FF9)  
    Dehydroxanthan Gum (UNII: 63ZP7I1BQO)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ammonia (UNII: 5138Q19F1X)  
    Tert-Butyl Alcohol (UNII: MD83SFE959)  
    Denatonium Benzoate (UNII: 4YK5Z54AT2)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57524-015-0145 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/15/2020
    Labeler - Kantian Skincare, LLC (078436984)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytogenX, Inc624386772MANUFACTURE(57524-015)
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