FDA.reportPublic FDA data

Soothe Night Time

Manufacturer
Bausch & Lomb Incorporated
Effective date
2024-09-24
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:22:05

Label at a glance#

ProductSoothe Night Time
Active ingredientMINERAL OIL, PETROLATUM
Label structure10 sections

Indications and uses

relieves dryness of the eye prevents further irritation

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Lubricant
Lubricant

Uses

INDICATIONS & USAGE SECTION

  • relieves dryness of the eye
  • prevents further irritation

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

none.

Other information

SPL UNCLASSIFIED SECTION

  • 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?

OTC - QUESTIONS SECTION

[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

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
96687602CARTONCARTON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259196mineral oil 20 % / petrolatum 80 % Ophthalmic OintmentPSN8
1235262Soothe Night Time 20 % / 80 % Ophthalmic OintmentPSN8
1235262mineral oil 0.2 MG/MG / petrolatum 0.8 MG/MG Ophthalmic Ointment [Soothe Night Time]SBD8
259196mineral oil 0.2 MG/MG / petrolatum 0.8 MG/MG Ophthalmic OintmentSCD8
1235262Bausch & Lomb Soothe Night Time (mineral oil 20 % / petrolatum, white 80 % ) Ophthalmic OintmentSY8
259196mineral oil 20 % / petrolatum 80 % Ophthalmic OintmentSY8
1235262Soothe Night Time (mineral oil 20 % / petrolatum, white 80 % ) Ophthalmic OintmentSY8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-313-34Soothe Night Time3.5 g in 1 TUBEOINTMENT3.58

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-313SOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED]8Current NDC, Legacy NDC, 1 package rows20240927_638d3c3f-9960-43da-956e-0e28c77f533e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-313-34GM - Gram24208-3138ba2d21d-2b7d-4273-912c-20b17dfde80512025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGP1
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
MINERAL OILACTIVE MOIETYT5L8T28FGP1
PETROLATUMACTIVE MOIETY4T6H12BN9U1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24208-31324208-313-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soothe Night TimeWHITE PETROLATUM MINERAL OILBausch & Lomb Incorporated638d3c3f-9960-43da-956e-0e28c77f533e2024-09-24WarningsExact identifier
ndc (package): 24208-313-34
ndc (product): 24208-313
ndc11 (package): 24208031334
spl id: 22e15dc4-1977-7228-e063-6394a90a679a
spl set id: 638d3c3f-9960-43da-956e-0e28c77f533e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.