Label: GLOSSIER SOLUTION EXFOLIATING SKIN PERFECTOR liquid

  • 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 October 31, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients

    Salicylic Acid 0.5%

  • Purpose

    Acne Treatment

  • Uses

    • for the treatment/management of acne
    • penetrates pores to reduce acne
    • helps prevent new acne from forming

  • Warnings

    For external use only
    When using this product
    • avoid contact with the eyes
    • if contact occurs, rinse thoroughly with water
    • skin irritation and dryness are more likely to occur when
    using another topical acne product at the same time. If irritation
    occurs, use only one product at a time
    Stop use and ask a doctor
    • if you develop severe irritation, burning, or itching of the skin
    • for more severe cases, and/or if improvement is not
    apparent within 6-8 weeks, consult a health care professional
    • if you develop hives, swelling of eyes and mouth, blistering,
    or dif culty breathing, get medical help right away

    Sunburn Alert: This product contains an alpha hydroxy acid
    (AHA) that may increase your skin’s sensitivity to the sun and
    particularly the possibility of sunburn. Use a sunscreen, wear

    protective clothing, and limit sun exposure while using this
    product and for a week afterwards.

  • Keep out of reach of children

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

  • 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

  • Inactive Ingredients

    Aqua/Water/Eau, Sodium Hydroxide, Lactic Acid, Glycolic
    Acid, Gluconolactone, Propanediol, Ethoxydiglycol, Magnesium
    Chloride, Glycereth-7 Trimethyl Ether, Niacinamide, Betaine,
    Inositol, Citric Acid, Glycerin, Phytic Acid, Pentylene
    Glycol, PEG-60 Hydrogenated Castor Oil, Caprylyl Glycol,
    Ethylhexylglycerin, Parfum/Fragrance, PEG-8, Aloe Barbadensis
    Leaf Juice, Acetic Acid, Potassium Hydroxide.

  • Other Information

    Protect this product in this container from
    excessive heat and direct sun.

  • Questions or comments?

    visit Glossier.com, email us at gTEAM@glossier.com, or call
    toll-free 1-844-654-8326

  • Principal Display Panel

    71425-020

  • INGREDIENTS AND APPEARANCE
    GLOSSIER SOLUTION EXFOLIATING SKIN PERFECTOR 
    glossier solution exfoliating skin perfector liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71425-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDRIDE (UNII: 23J3BHR95O)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    GLYCERETH-7 TRIMETHYL ETHER (UNII: XMC7402M60)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BETAINE (UNII: 3SCV180C9W)  
    INOSITOL (UNII: 4L6452S749)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71425-020-131 in 1 CARTON11/30/2017
    1130 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/30/2017
    Labeler - Glossier Inc. (078541007)
    Registrant - Glossier Inc. (078541007)
    Establishment
    NameAddressID/FEIBusiness Operations
    Thibiant International, Inc.083913913manufacture(71425-020)