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 – 800 mL Box Label

Henry Schein

112-5988

Maxiclens

Instant Hand Sanitizer

NDC 0404-5988-01

27.05 FL. OZ. (800 ML)

PRINCIPAL DISPLAY PANEL – 800 mL Box Label

PRINCIPAL DISPLAY PANEL – 1.68 mL Pouch

Henry Schein

Maxiclens

Instant Hand

Sanitizer

Citrus Scent

To Order: Contact your

Henry Schein Sales Rep

0.0570 fl.oz. (1.68 ML)

Distributed by

HENRY SCHEIN, Inc.

Melville, NY 11747 USA

Made in U.S.A.

PRINCIPAL DISPLAY PANEL – 1.68 mL Pouch
INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-5988
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol 665 mL  in 1000 mL
Inactive Ingredients
Ingredient Name Strength
aloe (UNII: V5VD430YW9)  
water (UNII: 059QF0KO0R)  
trolamine (UNII: 9O3K93S3TK)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0404-5988-01 800 mL in 1 BOX
2 NDC:0404-5988-02 1.68 mL in 1 POUCH
3 NDC:0404-5988-03 237 mL in 1 BOTTLE, PUMP
4 NDC:0404-5988-04 473 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 02/07/2012
Labeler - Henry Schein, Inc. (012430880)
Registrant - Safetec of America, Inc. (874965262)
Establishment
Name Address ID/FEI Business Operations
Safetec of America, Inc. 874965262 MANUFACTURE(0404-5988)

Revised: 1/2013
Document Id: 380f0f50-a4fe-44f5-b48f-b9879212fd22
Set id: 3b075cdc-509d-4259-99a2-0e219998949d
Version: 2
Effective Time: 20130116
 
Henry Schein, Inc.