Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID b254d885-6d49-4c95-b6be-cfdad49c85e6
Route
OPHTHALMIC
Published
Effective Date 2022-11-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Light Mineral Oil (10 mg) Mineral Oil (45 mg)
Inactive Ingredients
Boric Acid Edetate Disodium Octoxynol-40 Polysorbate 80 Water Sodium Borate Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-04-18

Description

Light mineral oil (1.0%) Mineral oil (4.5%)

Purpose

Emollient Emollient


Medication Information

Purpose

Emollient

Emollient

Description

Light mineral oil (1.0%) Mineral oil (4.5%)

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

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
Do Not Use
  • if solution changes color
  • if single-unit dispenser is not intact
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

Other Information
  • temporarily blurred vision is typical upon application
  • drops appear as a milky white solution
  • store at 15-25 °C (59-77 °F)
Active Ingredients

Light mineral oil (1.0%)

Mineral oil (4.5%)

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).

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.

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


Structured Label Content

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
Purpose

Emollient

Emollient

Warnings

For external use only

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
Do Not Use (Do not use)
  • if solution changes color
  • if single-unit dispenser is not intact
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

Other Information (Other information)
  • temporarily blurred vision is typical upon application
  • drops appear as a milky white solution
  • store at 15-25 °C (59-77 °F)
Active Ingredients (Active ingredients)

Light mineral oil (1.0%)

Mineral oil (4.5%)

Inactive Ingredients (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).

When Using This Product (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 (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Package/label Principal Display Panel (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


Advanced Ingredient Data


Raw Label Data

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