SOOTHE XP PRESERVATIVE FREE- 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
•
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

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

SOOTHE XP PRESERVATIVE FREE 
light mineral oil and mineral oil solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24208-742
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:24208-742-0130 in 1 CARTON04/18/2018
10.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
2NDC:24208-742-995 in 1 POUCH08/22/2018
20.3 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34904/18/2018
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoire Unither574139809MANUFACTURE(24208-742)

Revised: 11/2022
Document Id: bc77777a-9889-478f-ace3-18497e297337
Set id: b254d885-6d49-4c95-b6be-cfdad49c85e6
Version: 5
Effective Time: 20221111
 
Bausch & Lomb Incorporated