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Drug Facts
Hand Sanitizer
FDA Label NDC 0404-4445
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein, Inc. for the product Hand Sanitizer (NDC 0404-4445). 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 - do not use, otc - stop use, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Benzalkonium Chloride 0.39%
Purpose
Antiseptic
Uses
- for handwashing to decrease bacteria on skin without soap and water
- recommended for repeated use
Warnings
For external use only. Flammable, keep away from fire or flame
Otc - Do Not Use
Do not use in the eyes. If this happens, rinse thoroughly with water
Otc - Stop Use
Stop use and ask doctor if irritation and redness develop and persists for more than 72 hours
Keep Out Of Reach Of Children
If ingested get medical help or contact a Poison Control Center right away
Directions
- wet hands thoroughly with product
- allow to dry without wiping
- children under 6 should be supervised while using this product
Inactive Ingredients
aloe vera, propylene glycol, fragrance, purified water, germaben II, ganex p-904 LC
Distributed by:
Distribuido por: Distribuépar:
HENRY SCHEIN, Inc.
135 Duryea Road
Melville, NY 11747 USA
Made in U.S.A.
Principal Display Panel – 50 Ml Bottle Label
Henry Schein
Hand Sanitizer
Mountain Meadow
Jabón higiénico
de manos
Désinfectant pour
les mains
Foaming
Alcohol Free
1.7 fl. oz. (50 ml)
Principal Display Panel – 50 mL Bottle Label (Hen0a 0001 01)
* Please review the disclaimer below.
