Ics3 Blue Healthcare Hand Antiseptic
FDA Label NDC 81232-161

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Biocentris Pharmaceuticals, Llc for the product Ics3 Blue Healthcare Hand Antiseptic (NDC 81232-161). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Ethyl Alcohol 72% (v/v)

Otc - Purpose

Purpose

Antiseptic

Indications & Usage

Uses

For hand washing to decrease bacteria on the skin after changing diapers, after assisting ill persons or before contact with a person under medical care or treatment. Recommended for repeated use.

Warnings

Warnings

  • For external use only. Keep out of eyes, ears or mouth.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

    • FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME

Dosage & Administration

Directions

  • If hands are visibly soiled, wash with soap and water and dry hands.
  • Wet hands thoroughly with product, especially the area under the fingernails and allow to dry without rinsing

Inactive Ingredient

Inactive ingredients Benzalkonium chloride, caprylyl glycol, cetrimonium chloride, chlorhexidine gluconate, Di-PPG-2 myreth-10 adipate, 1,2-hexanediol, isopropyl alcohol, PEG 10 dimethicone, PEG-14M, phenoxyethanol, polyquaternium 10, PPG-3 myristyl ether, water

Package Label.Principal Display Panel

ICS3®

INFECTION CONTROL SYSTEM 3

HEALTHCARE HAND ANTISEPTIC

ETHYL ALCOHOL FOAM

16.9 FL OZ (500 mL)

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