Active Ingredient
Ethanol (62%)
Instant Hand Sanitizer
FDA Label NDC 64064-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Evonik Stockhausen, Llc for the product Instant Hand Sanitizer (NDC 64064-002). 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 active ingredient, purpose, uses, warnings, stop use and ask doctor if, keep out of reach of children., directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hand Antiseptic
Uses
Hand antiseptic to decrease bacteria on the skin.
Warnings
Flammable, For external use only.
Avoid contact with eyes. In case of accidental eye contact, flush eyes thoroughly with water.
Discontinue use if irritation and redness develops.
Stop Use And Ask Doctor If
Skin or eye irritation persists for more than 72 hours
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Dispense an adequate amount (approx. 5 mL), rubbing all surfaces of both hands for at least 15 seconds.
- Allow to dry without wiping.
Inactive Ingredients
Deionized Water, Isopropanol, Hydrogenated Starch Hydrolysate, Carbomer, THP Ethylendiamine, Fragrance
Principal Display Panel
NDC 64064-002-04
Instant Hand
Sanitizer
No Rinsing
Desinfectant
Instantane Pour Les Mains
Sans Rincage
Clinishield
Manufactured in U.S.A.
Fabrique Aux E.-U.
Evonik Stockhausen, LLC
Greensboro, NC 27406
1-800-334-0242 www.CliniShield.com
Imported by
Trans Canada Distribution Inc.
Mississauga, ON L5L 5Y7
Net Contents 32.82 Fl Oz(1000 mL)
Contenu Net 1 L
Stock No. 31795
No. De Stock 31795
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