INSTANT HAND SANITIZER- alcohol gel 
Graphic Controls

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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Instant Hand Sanitizer

Drug Facts

Active ingredient

Ethyl Alcohol 66.5%

Pupose

Antiseptic

Uses

Warnings

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

Do not use in the eyes. If this happens, rinse thoroughly with water

Stop use and ask a doctor if irritation and redness develop and persists for more than 72 hours

Keep out of reach of children

If ingested get medical help or contact a Poison Control Center right away

Directions

Inactive ingredients

aloe vera, carbomer, D&C green #5, D&C yellow #10, fragrance, purified water, triethanolamine

Manufactured for Graphic Controls LLC
Buffalo, NY 14204
1-800-669-1535

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – BOTTLE

FREE Sample-Not for Resale

GRAPHIC CONTROLS LLC – Instant Hand Sanitizer

For more information or To Order call

800-665-1535

www.graphiccontrols.com

Kills 99.99% of Germs

Enriched with Aloe Vera

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – BOTTLE
INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49959-1111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol.60 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aloe (UNII: V5VD430YW9)  
D&C Green No. 5 (UNII: 8J6RDU8L9X)  
D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
Colorgreen (green) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49959-1111-059 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart33311/30/2009
Labeler - Graphic Controls (002111896)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc874965262MANUFACTURE

Revised: 11/2009
Document Id: 8b28802d-c750-4607-a01c-4ebaa25e115f
Set id: c298118e-ff72-4dcc-8804-9c1f4b6a46b5
Version: 2
Effective Time: 20091109
 
Graphic Controls