FDA.reportPublic FDA data

Soothe XP Preservative Free

Manufacturer
Bausch & Lomb Incorporated | Laboratoire Unither
Effective date
2024-09-20
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:19:58

Label at a glance#

ProductSoothe XP Preservative Free
Active ingredientLIGHT MINERAL OIL, MINERAL OIL
Label structure9 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Light mineral oil (1.0%)

Mineral oil (4.5%)

Purpose

OTC - PURPOSE SECTION

Emollient

Emollient

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

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

  • 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

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call: 1-800-553-5340

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
577927light mineral oil 1 % / mineral oil 4.5 % Ophthalmic SolutionPSN6
1594962Soothe XP Mineral Oil 1 % / 4.5 % Ophthalmic SolutionPSN6
1594962mineral oil 45 MG/ML / mineral oil, light 10 MG/ML Ophthalmic Solution [Soothe Mineral Oil]SBD6
577927mineral oil 45 MG/ML / mineral oil, light 10 MG/ML Ophthalmic SolutionSCD6
577927mineral oil 4.5 % / mineral oil, light 1 % Ophthalmic SolutionSY6
1594962mineral oil 4.5 % / mineral oil, light 1 % Ophthalmic Solution [Soothe Mineral Oil]SY6
1594962Soothe Mineral Oil 4.5 % / 1 % Ophthalmic SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-742-01Soothe XP Preservative Free0.3 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.36
24208-742-01Soothe XP Preservative Free30 in 1 CARTONSOLUTION/ DROPS306
24208-742-99Soothe XP Preservative Free0.3 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.36
24208-742-99Soothe XP Preservative Free5 in 1 POUCHSOLUTION/ DROPS56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-742SOOTHE XP PRESERVATIVE FREE (LIGHT MINERAL OIL AND MINERAL OIL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]6Current NDC, Legacy NDC, 4 package rows20240922_b254d885-6d49-4c95-b6be-cfdad49c85e6.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24208-74224208-742-01, 24208-742-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
OCTOXYNOL-409T1C662FKSIACT
POLYSORBATE 806OZP39ZG8HIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
LIGHT MINERAL OILN6K5787QVPACTIB
MINERAL OILT5L8T28FGPACTIB

Source Document#

Source XML · Source PDF

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 XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
ndc (package): 24208-742-99
ndc (package): 24208-742-01
ndc (product): 24208-742
ndc11 (package): 24208074299
ndc11 (package): 24208074201
spl id: 2298b766-e9e4-0319-e063-6394a90a50dc
spl set id: b254d885-6d49-4c95-b6be-cfdad49c85e6

Reported adverse events (FAERS/openFDA)#

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