Label: SOOTHE XP- light mineral oil and mineral oil solution/ drops 

  • Label RSS
  • NDC Code(s): 24208-490-15
  • Packager: Baush & Lomb Incorporated
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/10

If you are a consumer or patient please visit this version.

  • Active ingredient

    Light mineral oil (1.0%)

    Mineral oil (4.5%)

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  • Purpose

    Emollient

    Emollient

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  • 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
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  • 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.

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  • 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
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  • Other Information

    temporarily blurred vision is typical upon application

    • drops appear as a milky white solution
    • store at 15°-25°C (59°-77°F)
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  • 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.

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  • 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

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  • 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.

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  • INGREDIENTS AND APPEARANCE
    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 (LIGHT MINERAL OIL) LIGHT MINERAL OIL 0.15 mL  in 15 mL
    MINERAL OIL (MINERAL OIL) MINERAL OIL 0.675 mL  in 15 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 NDC:24208-490-15 1 in 1 BOX
    1 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 08/26/2010
    Labeler - Baush & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 807927397 MANUFACTURE
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