Eyefull Pcd Kit
FDA Label NDC 80184-997

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rafac International Inc for the product Eyefull Pcd Kit (NDC 80184-997). 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, stop use and ask a doctor if, do not use, when using this product, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Ethyl Alcohol 75%

Purpose

Antiseptic

Uses

  • Hand sanitizer to help reduce bacteria that potentially cause disease. 
  • For use when soap and water are not available

Warnings

For external use only. Flammable. Keep away from heat or flame.

Stop Use And Ask A Doctor If

irritation or rash occurs. These may be signs of a serious condition.

Do Not Use

  • On children of less than 5 year of age.
  • On open skin wounds.

When Using This Product

keep out of eyes,ears,and mouth.In case of contact with eyes,rinse eyes thoroughly with water.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

  • Extract 1 wipe from pack, rub vigorously on and between fingers on both palms and hands, allow hands to dry.
  • Discard in trash receptacle after use.
  • Do not flush.

Other Information

  • Store in cool,dry place, between 15°-30°C(59°F-86°F).
  • Avoid freezing and excessive heat above 40°C(104°F).

Inactive Ingredients

Purified water USP

Package Labeling:80184-999-10

Label (Label)

Label (Label)

Bottle (Bottle)

Bottle (Bottle)

Package Labeling:  80184-996-10

Label2 (Label2)

Label2 (Label2)

Box (Box)

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