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NDC 24208-0742-99 Soothe XP Preservative Free 10; 45 mg/mL; mg/mL Details

Soothe XP Preservative Free 10; 45 mg/mL; mg/mL

Soothe XP Preservative Free is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Bausch & Lomb Incorporated. The primary component is LIGHT MINERAL OIL; MINERAL OIL.

Product Information

NDC	24208-0742
Product ID	24208-742_bc77777a-9889-478f-ace3-18497e297337
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Soothe XP Preservative Free
Proprietary Name Suffix	n/a
Non-Proprietary Name	light mineral oil and mineral oil
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	10; 45
Active Ingredient Units	mg/mL; mg/mL
Substance Name	LIGHT MINERAL OIL; MINERAL OIL
Labeler Name	Bausch & Lomb Incorporated
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24208-0742-99 (24208074299)

Pricing Information	N/A
NDC Package Code	24208-742-99
Billing NDC	24208074299
Package	5 VIAL, SINGLE-USE in 1 POUCH (24208-742-99) / .3 mL in 1 VIAL, SINGLE-USE
Marketing Start Date	2018-08-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b254d885-6d49-4c95-b6be-cfdad49c85e6 Details

Active ingredients

Light mineral oil (1.0%)

Mineral oil (4.5%)

Purpose

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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24208-742
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIGHT MINERAL OIL (UNII: N6K5787QVP) (LIGHT MINERAL OIL - UNII:N6K5787QVP)	LIGHT MINERAL OIL	10 mg in 1 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	45 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:24208-742-01	30 in 1 CARTON	04/18/2018
1		0.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2	NDC:24208-742-99	5 in 1 POUCH	08/22/2018
2		0.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	04/18/2018

Labeler - Bausch & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Laboratoire Unither		574139809	MANUFACTURE(24208-742)

Revised: 11/2022

Document Id: bc77777a-9889-478f-ace3-18497e297337

Set id: b254d885-6d49-4c95-b6be-cfdad49c85e6

Version: 5

Effective Time: 20221111