Sani Luxe Foaming Hand Sanitizer Alcohol Free Liquid
FDA Label NDC 71489-006

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Celeste Industries Corporation for the product Sani Luxe Foaming Hand Sanitizer Alcohol Free (NDC 71489-006). 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, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Uses

  • Recommended for repeated use
  • For hand sanitizing to decrease bacteria on the skin

Warnings

  • For external use only.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Otc - When Using

  • When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Otc - Stop Use

  • Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Pump a small amount of foam into palm of hand
  • Rub hands together briskly until dry
  • Rub thoroughly over all surfaces of both hands

Inactive Ingredients

Water (Aqua), Triethylene Glycol, Glycereth-26, Cocamidopropyl PG-Dimonium Cloride Phosphate,Hydroxyethylcellulose, DMDM Hydantoin, Triethanolamine, Fragrance (Aroma), Iodopropynyl Butyl Carbamate, 1, 3-Butanediol

Principal Display Panel - 236 Ml Bottle Label

SaniLuxe™

FOAMING HAND SANITIZER

Alcohol free

  • Requires no water or towels.
  • Apply small amount to hands
    and rub until dry.

    • Kills 99%
    of germs
    on contact

    Caution: Use on hands only.

    8 fl oz • 236ml e

    Principal Display Panel (236 ml Bottle Label)

    Principal Display Panel (236 ml Bottle Label)

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