Royal Alcohol Cleansing Pads
FDA Label NDC 50438-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Filo America for the product Royal Alcohol Cleansing Pads (NDC 50438-000). 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 royal alcohol cleansing pads, active ingredient, purpose, use, warning:, keep out of reach of children., caution, do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Royal Alcohol Cleansing Pads


Active Ingredient

Isopropyl Alcohol, 70% v/v

Purpose

Antiseptic

Use

for the preparation of skin prior to an injection to decrease germs in minor cuts and scrapes.

Warning:

For external use only

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a poison control center immediately.

Caution

do not apply to irritated skin.

Do Not Use

in the eyes or on mucous membranes.

In Case

of deep cuts or puncture wounds, consult a doctor.

Direction

wipe injection site vigorously.

Other Information

store at room temperature.

Inactive Ingredient

water

Package Label.Principal Display Panel

ROYAL ALCOHOL CLEANSING PADS

PRE-MOISTENED WIPES FOR EVERYDAY USE

  • Individually foil wrapped
  • 70% Isopropyl Alcohol

    • 100 INDIVIDUAL PACKS
    SAFE AND EAST TO USE
    STERILE unless individual wrapper is opened or damaged.

Royal Alcohol Cleansing Pads 100 Packs (50438-000-00)

Outer Label (Outerlabel)

Outer Label (Outerlabel)

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