INSTANT HAND SANITIZER- alcohol gel 
Safetec of America, 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.

----------

Drug Facts

Active Ingredient

Ethyl Alcohol 70%

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 develop 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, D&C yellow#10, fragrance, purified water, triethanolamine

Manufactured by SAFETEC OF AMERICA, Inc. Buffalo, NY 14215 800-456-7077 www.safetec.com

PRINCIPAL DISPLAY PANEL – 34,688 fl. oz. Container Label

NDC 61010-6111-0

Safetec

instant
Hand
Sanitizer

Kills 99.9% of Germs

Enriched with
Aloe Vera

Citrus

34,688 fl.oz. (1,026 L) Reorder No. 17391

PRINCIPAL DISPLAY PANEL – 34,688 fl. oz. Container Label
INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61010-6111
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
alcohol (alcohol) alcohol700 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
carbomer interpolymer type a (55000 mpa.s) 
water 
trolamine 
d&c yellow no. 10 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-6111-01026 L in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/11/2013
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(61010-6111)

Revised: 11/2013
Document Id: d3c94548-eea9-4291-9ca4-f29bfd860e16
Set id: 2d73f0d8-24dc-4866-b00f-54b31fbc4760
Version: 1
Effective Time: 20131111
 
Safetec of America, Inc.