Soothe Xp Solution/ Drops
FDA Label NDC 24208-490

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bausch & Lomb Incorporated for the product Soothe Xp (NDC 24208-490). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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

boric acid, edetate disodium, octoxynol-40, polyquarternium-1 (preservative), polysorbate 80, purified water, sodium borate decahydrate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions?

Call: 1-800-553-5340

Package/Label Principal Display Panel

BAUSCH + LOMB

Soothe® XP

Emollient (Lubricant) Eye Drops

XTRA PROTECTION

ADVANCED Dry Eye Therapy

With RestorylTM a unique combination

of mineral oils that:

- Moisturizes for fast relief

- Protects against tear loss

- Restores the lipid layer of tears

Sterile

0.5 FL OZ (15mL)

* Please review the disclaimer below.