SANIKLEAN E3 HAND SANITIZER- alcohol liquid 
Bunzl Processor Distribution LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Ethyl Alcohol 70% (v/v)

Purpose

Hand Sanitizer

Uses

Hand wash to help reduce bacteria that potentially can cause diseases

Helps prevent cross contamination by hand contact

Helps prevent drying and chafing of skin

Recommended for repeated use

Warnings

For External use only

Flammable, keep away from fire or flame


When using this product

Do not use in or near eyes

Use in well-ventilated area

Discontinue use if irritation and/or redness develops

Keep out of reach of children.

In case of accidental ingestion, seek medical attention or contact Poison Control Center immediately

Directions

Wet hands thoroughly with product, covering entire surface of hands, including fingertips, cuticles, wrists and forearms

Rub vigorously into skin until dry

No rinsing or toweling required

Store in a cool dry place below 104 F

For Food Processing, Food Service and Professional Use Only

NDC 21532-1410-1

Inactive Ingredients

Purified Water, Glycerin

SaniKleen

E3 Hand Sanitizer

Marketed By:

Bunzl

528 East 19th Avenue

North Kansas City, MO 64116

CONTENTS: 1 Gallon

container label


SANIKLEAN E3 HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21532-1410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21532-1410-13785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/05/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2006
Labeler - Bunzl Processor Distribution LLC (007169634)
Establishment
NameAddressID/FEIBusiness Operations
Central Solutions Inc007118524manufacture(21532-1410)

Revised: 12/2018
Document Id: 076ca5e3-b404-4ace-be9a-a015715299a5
Set id: 5d7a0dad-41de-47d7-bb33-6ae93208ded5
Version: 2
Effective Time: 20181205
 
Bunzl Processor Distribution LLC