Soothe Night Time Ointment
FDA Label NDC 24208-313

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 Night Time (NDC 24208-313). 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, keep out of reach of children., directions, other information, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Mineral oil (20%)
White petrolatum (80%)

Purpose

Lubricant

Uses

  • relieves dryness of the eye
  • prevents further irritation

Warnings

When using this product  

  • do not touch tip of container to any surface to avoid contamination
  • do not use with contact lenses
  • replace cap after use

    • Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • 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

  • pull down the lower lid of the affected eye
  • apply a small amount (1/4 inch) of ointment to the inside of eyelid
  • apply one or more times daily

Other Information

  • store at 15° - 25°C (59° - 77°F)
  • keep tightly closed
  • see crimp of tube or carton for Lot Number and Expiration Date
  • use before expiration date marked on the carton and tube
  • serious side effects associated with use of the product may be reported to the phone number below

    •  

Questions?

Call: 1-800-553-5340

Package/Label Principal Display Panel

pm [with moon and stars icon]

BAUSCH + LOMB

Soothe®

Lubricant Eye Ointment

  • For overnight relieve of severe dry eye
  • Preservative Free

    NIGHT TIME

    Dry Eye Therapy

    • NET WT 1/8 OZ (3.5 g)

* Please review the disclaimer below.