SOOTHE XP- light mineral oil and mineral oil solution/ drops 
Bausch & Lomb Incorporated

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

carton

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

SOOTHE XP 
light mineral oil and mineral oil solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-490
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP) (LIGHT MINERAL OIL - UNII:N6K5787QVP) LIGHT MINERAL OIL10 mg  in 1 mL
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL45 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24208-490-151 in 1 BOX08/26/2010
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:24208-490-302 in 1 BOX08/26/2010
215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC:24208-490-951 in 1 BOX08/26/2010
32.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/26/2010
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated079587625MANUFACTURE(24208-490)

Revised: 9/2022
Document Id: 4923b99e-7c6a-4b9d-a15d-b96be25af237
Set id: c0f053da-8d22-433e-a36e-79cf15ad387f
Version: 11
Effective Time: 20220929
 
Bausch & Lomb Incorporated