FDA.reportPublic FDA data

Soothe XP

Manufacturer
Bausch & Lomb Incorporated
Effective date
2024-09-20
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 00:19:58

Label at a glance#

ProductSoothe XP
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 instill 1 or 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

When using this product

OTC - WHEN USING SECTION

  • do not touch the tip of container to any surface
  • replace cap after using

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
  • instill 1 or 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, polyquaternium-1 (preservative), polysorbate 80, purified water, sodium borate decahydrate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions?

OTC - QUESTIONS SECTION

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

Marketed by:Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA
Patented. See patents.bausch.com
®/ TMare trademarks of Bausch & Lomb
Incorporated or its affiliates.
© 2022 Bausch & Lomb Incorporated
or its affiliates
Order No. AB49311

SootheEyeDrops.com

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton
carton

BAUSCH + LOMB

Soothe ®XP
Emollient (Lubricant) Eye Drops

XTRA
PROTECTION

Advanced Dry Eye Therapy

WITH RESTORYL ®
MINERAL OILSTHAT:

  • Restore
  • Seal
  • Protect

Sterile       0.5 FL OZ (15 mL)

AB49311
3839201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
577927light mineral oil 1 % / mineral oil 4.5 % Ophthalmic SolutionPSN12
1594962Soothe XP Mineral Oil 1 % / 4.5 % Ophthalmic SolutionPSN12
1594962mineral oil 45 MG/ML / mineral oil, light 10 MG/ML Ophthalmic Solution [Soothe Mineral Oil]SBD12
577927mineral oil 45 MG/ML / mineral oil, light 10 MG/ML Ophthalmic SolutionSCD12
577927mineral oil 4.5 % / mineral oil, light 1 % Ophthalmic SolutionSY12
1594962mineral oil 4.5 % / mineral oil, light 1 % Ophthalmic Solution [Soothe Mineral Oil]SY12
1594962Soothe Mineral Oil 4.5 % / 1 % Ophthalmic SolutionSY12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-490-15Soothe XP15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1512
24208-490-15Soothe XP1 in 1 BOXSOLUTION/ DROPS112
24208-490-30Soothe XP2 in 1 BOXSOLUTION/ DROPS212
24208-490-30Soothe XP15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS1512
24208-490-95Soothe XP2.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS2.512
24208-490-95Soothe XP1 in 1 BOXSOLUTION/ DROPS112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-490SOOTHE XP (LIGHT MINERAL OIL AND MINERAL OIL) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]12Current NDC, Legacy NDC, 6 package rows20240922_c0f053da-8d22-433e-a36e-79cf15ad387f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-490-15ML - Milliliter24208-490a8c933f6-bdc4-496d-9157-13085575079b12025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIGHT MINERAL OILACTIVE INGREDIENTN6K5787QVP4
MINERAL OILACTIVE INGREDIENTT5L8T28FGP4
LIGHT MINERAL OILACTIVE MOIETYN6K5787QVP4
MINERAL OILACTIVE MOIETYT5L8T28FGP4
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D44
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB4
OCTOXYNOL-40INACTIVE INGREDIENT9T1C662FKS4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H4
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QO4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I4
WATERINACTIVE INGREDIENT059QF0KO0R4

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
24208-49024208-490-15, 24208-490-30, 24208-490-95

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
OCTOXYNOL-40OCTOXYNOL-409T1C662FKSSOLUTION/ DROPS / OPHTHALMICNAExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
OCTOXYNOL-40OCTOXYNOL-409T1C662FKSSOLUTION/ DROPS / OPHTHALMICNAExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
4 equally ranked IID candidates
OCTOXYNOL-40OCTOXYNOL-409T1C662FKSSOLUTION/ DROPS / OPHTHALMICNAExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
4 equally ranked IID candidates
OCTOXYNOL-40OCTOXYNOL-409T1C662FKSSOLUTION/ DROPS / OPHTHALMICNAExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION/ DROPS / OPHTHALMIC0.25 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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 XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
ndc (package): 24208-490-30
ndc (package): 24208-490-95
ndc (package): 24208-490-15
ndc (product): 24208-490
ndc11 (package): 24208049095
ndc11 (package): 24208049015
ndc11 (package): 24208049030
spl id: 2299627f-c64e-d54f-e063-6294a90af656
spl set id: c0f053da-8d22-433e-a36e-79cf15ad387f

Reported adverse events (FAERS/openFDA)#

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