Emergency Eye Wash, Pw, Sterile
FDA Label NDC 51997-035

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Asept Pak, Inc. for the product Emergency Eye Wash, Pw, Sterile (NDC 51997-035). 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 other, active ingredients, purpose, indication, otc - when using, otc - do not use, otc - stop use, otc - 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

Other

Drug Facts

Manufactured by SterRx
64 West St., Malone, NY 12953

Active Ingredients

Purified water 99%

Purpose

Eyewash

Indication

For flushing the eyes to help relieve irritation, discomfort, burning, stinging or itching by removing loose foreign material and air pollutants (smog or pollen).

Otc - When Using

For external use only.

  • Obtain immediate medical treatment for all open wounds in or near the eye
  • To avoid contamination, do not touch tip of container to any surface
  • Do not reuse
  • Discard vial after use

Otc - Do Not Use

Do not use if:

  • Solution changes color or becomes cloudy
  • With contact lenses
  • If vial is open or seal is broken.

Otc - Stop Use

Stop use and consult a doctor if you experience:

  • Eye pain
  • Changes in vision
  • Continued redness or irritation of the eye or if the condition worsens or persists.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Twist top to remove
  • Wash the affected eye(s) as needed
  • Control rate of flow by pressure on the vial
  • If necessary, continue flushing with emergency eyewash or shower

Inactive Ingredients

  • Boric Acid
  • Sodium Borate
  • Sodium Chloride
  • Sorbic Acid

Questions

Call SterRx at (518) 651-2026

NDC 51997-035-05

Storage And Handling

Store at 41-95°F (5-35°C)

Principal Display Panel - 15 Ml Vial Label

TAMPER-EVIDENT CAP
DO NOT USE IF TWIST-OFF
TOP IS BROKEN OR MISSING

STERILE

EYE
WASH

FIRST AID
TREATMENT
FOR EYE

1/2 FL OZ (15 ml)

Store at 41-95°F (5-35°C)
Manufactured by SterRx
64 West St., Malone, NY 12953

Principal Display Panel (15 ml Vial Label)

Principal Display Panel (15 ml Vial Label)

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