Your browser does not support JavaScript! SOOTHE XP (LIGHT MINERAL OIL AND MINERAL OIL) SOLUTION/ DROPS [BAUSH & LOMB INCORPORATED]
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SOOTHE XP (light mineral oil and mineral oil) solution/ drops
[Baush & Lomb Incorporated]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

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

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.

Questions or Comments?

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 15 mL carton

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 to8 hours of comfort and relief becauseit contains Restoryl®, the advancedlipid 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24208-490
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIGHT MINERAL OIL (LIGHT MINERAL OIL) LIGHT MINERAL OIL0.15 mL  in 15 mL
MINERAL OIL (MINERAL OIL) MINERAL OIL0.675 mL  in 15 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
OCTOXYNOL-40 
POLYAMINOPROPYL BIGUANIDE 
POLYSORBATE 80 
WATER 
SODIUM CHLORIDE 
SODIUM HYDROXIDE 
HYDROCHLORIC ACID 
SODIUM PHOSPHATE, DIBASIC 
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24208-490-151 in 1 BOX
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34908/26/2010
Labeler - Baush & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated807927397MANUFACTURE

Revised: 8/2010
 
Baush & Lomb Incorporated

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