INSTANT HAND SANITIZER- alcohol gel 
Safetec of America

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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Safetec Instant Hand Sanitizer

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 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 green #5, 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

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

NDC 61010-1112-4

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with

Aloe Vera

Fresh

34,688 fl.oz. (1,026 L) Reorder No. 17382

PRINCIPAL DISPLAY PANEL – 34,688 fl. oz. Container Label
INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-1112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol665 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe (UNII: V5VD430YW9)  
water (UNII: 059QF0KO0R)  
trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-1112-41026 L in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:61010-1112-7208.2 L in 1 CONTAINER; Type 0: Not a Combination Product10/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E12/16/2010
Labeler - Safetec of America (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(61010-1112)

Revised: 10/2014
Document Id: 8cfb1b18-4e00-4265-87f5-a0971372d1e0
Set id: bf69cc74-ebe9-40c3-a95a-a489492cc693
Version: 2
Effective Time: 20141014
 
Safetec of America