Label: SOOTHE- glycerin and propylene glycol solution/ drops

  • NDC Code(s): 24208-495-28, 24208-495-30
  • Packager: Bausch & Lomb Incorporated
  • 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 31, 2023

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  • Active ingredients

    Glycerin (0.6%)

    Propylene glycol (0.6%)

  • Purpose

    Lubricant

    Lubricant

  • Uses

    •
    relieves dryness of the eye
    •
    prevents further irritation
  • Warnings

    For external use only
    Do not use

    •
    if solution changes color or becomes cloudy
    •
    if single-unit dispenser is not intact

    When using this product

    •
    do not touch tip of container to any surface to avoid contamination
    •
    once opened, discard
    •
    do not reuse

    Stop use and ask a doctor if

    •
    you experience eye pain, changes in vision, continued redness or irritation of the eye
    •
    condition worsens or persists for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    to open, completely twist off tab
    •
    instill 1 to 2 drops in the affected eye(s) as needed
    •
    discard dispenser immediately after use
  • Other information

    •
    store at 15 – 25 °C (59 – 77 °F)
  • Inactive ingredients

    boric acid, hydroxyalkylphosphonate, purified water, sodium alginate, sodium borate

  • Questions?

    [phone icon] Call: 1-800-553-5340

    Marketed by:
    Bausch & Lomb Americas Inc.
    Bridgewater, NJ 08807 USA

    Soothe is a trademark of|
    Bausch & Lomb Incorporated
    or its affiliates.

    © 2022 Bausch & Lomb
    Incorporated or its affiliates
    Product of France

  • Package/Label Principal Display Panel

    carton-3839601

    Bausch & Lomb
    Soothe®

    Lubricant Eye Drops

      PRESERVATIVE FREE

    Dry Eye Therapy

     
    Moisturizes
     
    Comforts
     
    Lasts
     
    Recommended
    for LASIK dryness*
     
    30 Single-Use Vials

    Sterile 0.02 FL OZ EA (0.6 mL EA)

    3839601

    SootheEyeDrops.com

    Order No. 622219

  • INGREDIENTS AND APPEARANCE
    SOOTHE 
    glycerin and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-495
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN6 mg  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-495-2828 in 1 CARTON08/26/201006/30/2022
    10.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:24208-495-3030 in 1 CARTON05/01/2020
    20.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34908/26/2010
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated114406598MANUFACTURE(24208-495)
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