INSTANT HAND SANITIZER- alcohol gel 
Henry Schein, Inc.

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 Ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses

Warnings

For external use only. Flammable, keep away from fire or flame

When using this product do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Stop use and ask doctor if

  • irritation and redness develops and 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

Inactive Ingredients

aloe vera, carbomer, fragrance, purified water, triethanolamine

Distributed by HENRY SCHEIN, INC. Melville, NY 11747 USA
Made in U.S.A.

PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label

Henry Schein

112-5991

Maxiclens

Instant Hand Sanitizer

NDC 0404-5991-01

27.05 FL. OZ. (800 ML)

PRINCIPAL DISPLAY PANEL – 27.05 fl. oz. Box Label
INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0404-5991
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol665 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
aloe (UNII: V5VD430YW9)  
water (UNII: 059QF0KO0R)  
trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0404-5991-01800 mL in 1 BOX; Type 0: Not a Combination Product02/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/01/2012
Labeler - Henry Schein, Inc. (012430880)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(0404-5991)

Revised: 1/2023
Document Id: d483d4b6-6fd8-4efa-ae66-ed740bb5e7eb
Set id: e80feb63-2c51-4164-806d-778e39e620e8
Version: 4
Effective Time: 20230112
 
Henry Schein, Inc.