Aquacil
FDA Label NDC 81232-170

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 Aquacil (NDC 81232-170). 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

Benzalkonium Chloride 0.1% w/w

Otc - Purpose

Purpose

Antiseptic

Indications & Usage

Uses

  • Handwash to help reduce bacteria on the skin that potentially can cause disease.
  • Recommended for repeated use.

Warnings

Warnings

  • For external use only. Keep out of eyes, ears or mouth. In case of eye contact, flush eyes with water.

Otc - Stop Use

  • Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

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.

Dosage & Administration

Directions

  • Pump sufficient amount of foam into palm of hand.
  • Wet all surfaces of both hands thoroughly with product, including the area under the fingernails and rub until dry.

Inactive Ingredient

Inactive ingredients Cetrimonium chloride, laurtrimonium chloride, phenoxyethanol, stearalkonium chloride, water

Package Label.Principal Display Panel

AQUACIL ™
INSTANT FOAMING HAND SANITIZER

KILLS 99.9% OF GERMS
Alcohol Free Formula

Benzalkonium Chloride 0.1%
For Use Without Water

biocentris PHARMACEUTICALS
888-497-4375
[email protected]
www.biocentrispharmaceuticals.com

50 ml

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