Label: SOOTHE NIGHT TIME- white petrolatum mineral oil ointment

  • NDC Code(s): 24208-313-34
  • Packager: Bausch & Lomb Incorporated
  • 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 January 26, 2023

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  • Active ingredients

    Mineral oil (20%)
    White petrolatum (80%)

  • Purpose

    Lubricant
    Lubricant

  • Uses

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

    When using this product  

    •
    do not touch tip of container to any surface to avoid contamination
    •
    do not use with contact lenses
    •
    replace cap after use

    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

    •
    pull down the lower lid of the affected eye
    •
    apply a small amount (1/4 inch) of ointment to the inside of the eyelid
    •
    apply one or more times daily
  • Other information

    •
    store at 15-25 °C (59-77 °F)
    •
    keep tightly closed
    •
    see crimp of tube or carton for Lot Number and Expiration Date
    •
    use before expiration date marked on the carton and tube
    •
    serious side effects associated with use of the product may be reported to the phone number below  
  • 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

    SootheEyeDrops.com

    Order No. AB31336

  • Package/Label Principal Display Panel

    BAUSCH + LOMB

    Soothe®
    Lubricant Eye Ointment

    NIGHTTIME

    PRSERVATIVE FREE

    Dry Eye Therapy

    pm [with moon and stars icon]

    For nighttime relief
    of severe dry eye

    NET WT 1/8 OZ (3.5 g)

    AB31336
    96687602CARTON

  • INGREDIENTS AND APPEARANCE
    SOOTHE NIGHT TIME 
    white petrolatum mineral oil ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-313
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL200 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM800 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24208-313-343.5 g in 1 TUBE; Type 0: Not a Combination Product11/15/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/15/2011
    Labeler - Bausch & Lomb Incorporated (196603781)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated079587625MANUFACTURE(24208-313)
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