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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INSTANT HAND SANITIZER – alcohol gel

Safetec of America, Inc.

Instant Hand Sanitizer

Drug Facts

Active Ingredient

Ethyl Alcohol 70%

Purpose

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

Supplied by

STATINA

HEALTHCARE AUSTRALIA

3/12 Yatala Rd.

Mt. Kuring-Gai, NSW, 2080

1300 365 404

www.statina.com.au

PRINCIPAL DISPLAY PANEL

NDC 61010-4111-0

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with

Aloe Vera

Fresh

16 FL. OZ. (473 ML)

Reorder No. 17358

PRINCIPAL DISPLAY PANEL
INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol0.7 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
aloe (UNII: V5VD430YW9)  
water (UNII: 059QF0KO0R)  
trolamine (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61010-4111-0473 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/15/2010
Labeler - Safetec of America (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE

Revised: 9/2010
Document Id: 61b46712-2151-4e32-8f25-141c3cbddc04
Set id: 3784c55f-928f-4766-902a-d09ba1ed42ae
Version: 1
Effective Time: 20100915
 
Safetec of America