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Soothe XP

Baush & Lomb Incorporated

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Light mineral oil (1.0%)

Mineral oil (4.5%)

Purpose

Emollient

Emollient

Soothe XP 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

edetate disodium, octoxynol-40, polyhexamethylene biguanide (preservative), polysorbate-80, purified water, sodium chloride, sodium hydroxide and/or hydrochloric acid (to adjust pH), sodium phosphate dibasic, sodium phosphate monobasic.

Toll Free Product

Information or to

Report a Serious Side

Effect Associated with

use of the product

Call: 1-800-553-5340

Package/Label Principal Display Panel

Soothe XP

Soothe XP

Emollient (Lubricant)

Eye Drops

Xtra Protection

DRY EYE THERAPY

DUAL ACTION

- Moisturizes for fast relief

- Protects against tear loss

UP TO 8 HOURS OF RELIEF

Restores the lipid layer of tears

Ordinary lubricant eye drops simply provide moisture which can evaporate quickly from the eye’s surface.

Soothe®XP:

  • Provides moisture for fast relief AND
  • Protects against tear loss for up to 8 hours of comfort and relief because it contains Restoryl®, the advanced lipid restorative

Expect temporarily blurred vision upon application, as Soothe®XP eye drops seal in moisture.

Bausch & Lomb, Soothe and Restoryl are registered trademarks of Bausch & Lomb Incorporated.

US Patent #5,578,586

© Bausch & Lomb Incorporated

Rochester, NY 14609        Order No. AB49011

TAMPER EVIDENT: DO NOT USE IF

IMPRINTED “Protective Seal” NECKBAND

WITH YELLOW "Mortar and Pestle Symbol" IS NOT INTACT.

Soothe XP

light mineral oil and mineral oil SOLUTION/ DROPS

Product Information

Product Type Human otc drug label Item Code (Source) NDC:24208-490
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LIGHT MINERAL OIL 0.15 mL
Mineral Oil 0.675 mL

Inactive Ingredients

Ingredient Name Strength
EDETATE DISODIUM
octoxynol-40
POLYAMINOPROPYL BIGUANIDE
polysorbate 80
water
SODIUM CHLORIDE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
SODIUM PHOSPHATE, DIBASIC
Sodium Phosphate, Monobasic, Monohydrate

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15 in 1 BOTTLE, DROPPER
2 NDC:24208-490-15 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2010-08-26


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