Refill 6 Kit
FDA Label NDC 49687-0019

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cmc Group, Inc. for the product Refill 6 (NDC 49687-0019). 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 ingredient, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Ethyl alcohol 62%

Purified Water 99.1%

Purpose

Antiseptic

Eyewash

Uses

  • For handwashing to decrease bacteria on the skin
    • Recommended for repeated use.

Warnings

Flammable, keep away from fire or flame
For external use only.

For external use only.

Do Not Use

  • in the eyes.

    • if solution changes color or becomes cloudy

Stop Use And Ask A Doctor If

  • irritation and redness develop
    • condition persists for more than 72 hours

      • • you experience: • eye pain • changes in vision • continued redness • irritation of the eye • condition worsens or persists

Keep Out Of Reach Children.

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

Directions

  • Wet hands thoroughly with product and allow to dry without wiping.

    • • Flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle

Other Information

Store at 15° to 25°C (59° to 77°F)

• not for use as contact lens solution

• use before expiration date marked on the bottle

• store at room temperature, 5° to 35°C (41° to 95°F)

Inactive Ingredients

Carbomer, propylene glycol, purified water, titanium dioxide

Benzalkonium chloride, sodium chloride

Use

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

When Using This Product

• to avoid contamination, do not touch tip of container to any surface • do not reuse • once opened, discard • obtain immediate medical treatment for all open wounds in or near the eyes

Keep Out Of Reach Of Children.

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

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