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NDC 24208-0490-95 Soothe XP 10; 45 mg/mL; mg/mL Details

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

Soothe XP 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	24208-0490
Product ID	24208-490_4923b99e-7c6a-4b9d-a15d-b96be25af237
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
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 24208-0490-95 (24208049095)

Pricing Information	N/A
NDC Package Code	24208-490-95
Billing NDC	24208049095
Package	1 BOTTLE, DROPPER in 1 BOX (24208-490-95) / 2.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2010-08-26
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c0f053da-8d22-433e-a36e-79cf15ad387f Details

Active ingredients

Light mineral oil (1.0%)

Mineral oil (4.5%)

Purpose

Emollient

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

When using this product

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

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

Questions?

[phone icon] 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. AB49311

SootheEyeDrops.com

Package/Label Principal Display Panel

BAUSCH + LOMB

Soothe® XP

Emollient (Lubricant) Eye Drops

XTRA

PROTECTION

Advanced Dry Eye Therapy

WITH RESTORYL®

MINERAL OILS THAT:

•: Restore
•: Seal
•: Protect

Sterile 0.5 FL OZ (15 mL)

AB49311

3839201

INGREDIENTS AND APPEARANCE

SOOTHE XP

light mineral oil and mineral oil solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24208-490
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:24208-490-15	1 in 1 BOX	08/26/2010
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:24208-490-30	2 in 1 BOX	08/26/2010
2		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC:24208-490-95	1 in 1 BOX	08/26/2010
3		2.5 mL in 1 BOTTLE, DROPPER; 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	08/26/2010

Labeler - Bausch & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		079587625	MANUFACTURE(24208-490)

Revised: 9/2022

Document Id: 4923b99e-7c6a-4b9d-a15d-b96be25af237

Set id: c0f053da-8d22-433e-a36e-79cf15ad387f

Version: 11

Effective Time: 20220929