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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:61010-6111
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol 700 mg  in 1 L
Inactive Ingredients
Ingredient Name Strength
aloe vera leaf (UNII: ZY81Z83H0X)  
carbomer interpolymer type a (55000 mpa.s) (UNII: 59TL3WG5CO)  
water (UNII: 059QF0KO0R)  
trolamine (UNII: 9O3K93S3TK)  
d&c yellow no. 10 (UNII: 35SW5USQ3G)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61010-6111-0 1026 L in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 11/11/2013
Labeler - Safetec of America, Inc. (874965262)
Establishment
Name Address ID/FEI Business Operations
Safetec of America, Inc. 874965262 MANUFACTURE(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.