Label: SOOTHE XP PRESERVATIVE FREE- light mineral oil and mineral oil solution/ drops

  • NDC Code(s): 24208-742-01, 24208-742-99
  • 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.

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Updated November 11, 2022

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  • Active ingredients

    Light mineral oil (1.0%)

    Mineral oil (4.5%)

  • Purpose

    Emollient

    Emollient

  • Uses

    •
    temporary relief of burning and irritation due to dryness of the eye
    •
    temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
    •
    as a protectant to prevent further irritation or to relieve dryness of the eye
  • Warnings

    For external use only

    Do not use

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

    When using this product

    •
    do not touch the 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, or if 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

    •
    remove contact lenses before use
    •
    shake well before using
    •
    to open, completely twist off tab
    •
    instill 1 to 2 drop(s) in the affected eye(s) as needed or as directed by your doctor
  • Other information

    •
    temporarily blurred vision is typical upon application
    •
    drops appear as a milky white solution
    •
    store at 15-25 °C (59-77 °F)
  • Inactive ingredients

    boric acid, edetate disodium, octoxynol-40, polysorbate 80, purified water, sodium borate decahydrate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

  • Questions?

    Call: 1-800-553-5340

    Marketed by:
    Bausch & Lomb Americas Inc.
    Bridgewater, NJ 08807 USA
    Patented. See https://patents.bausch.com
    ®/TM are trademarks of Bausch & Lomb Incorporated
    or its affiliates.
    © 2022 Bausch & Lomb Incorporated or its affiliates
    Order No. 622238
    Product of France

    3827804
    SootheEyeDrops.com

  • Package/Label Principal Display Panel

    carton

    BAUSCH + LOMB

    Soothe® XP

    Emollient (Lubricant) Eye Drops

    XTRA PROTECTION

    Preservative Free

    Advanced Dry Eye Therapy

    With Restoryl®

    mineral oils that:

    • Restore

    • Seal

    • Protect

    30 Single-Use Vials

    0.01 FL OZ EA (0.3 mL EA)

    Sterile

  • INGREDIENTS AND APPEARANCE
    SOOTHE XP PRESERVATIVE FREE 
    light mineral oil and mineral oil solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-742
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP) (LIGHT MINERAL OIL - UNII:N6K5787QVP) LIGHT MINERAL OIL10 mg  in 1 mL
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OCTOXYNOL-40 (UNII: 9T1C662FKS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-742-0130 in 1 CARTON04/18/2018
    10.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:24208-742-995 in 1 POUCH08/22/2018
    20.3 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 finalpart34904/18/2018
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoire Unither574139809MANUFACTURE(24208-742)
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