Instant Hand Sanitizer by Safetec of America, Inc.

Instant Hand Sanitizer by

Drug Labeling and Warnings

Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Safetec of America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

  • for handwashing to decrease bacteria on skin whenever soap and water handwashing is not readily available
  • helps prevent the risk of cross-contamination of bacteria that potentially can cause disease or infection
  • recommended for repeated use

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

  • place a small amount into one hand
  • spread over both hands and wrist
  • rub into the skin until dry
  • do not wipe off; no rinsing required

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 DRUGItem Code (Source)NDC: 61010-6111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
alcohol (UNII: 3K9958V90M) (alcohol - UNII:3K9958V90M) alcohol700 mg  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf (UNII: ZY81Z83H0X)  
carbomer interpolymer type a (allyl sucrose crosslinked) (UNII: 59TL3WG5CO)  
water (UNII: 059QF0KO0R)  
trolamine (UNII: 9O3K93S3TK)  
d&c yellow no. 10 (UNII: 35SW5USQ3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 61010-6111-01026 L in 1 CONTAINER; Type 0: Not a Combination Product11/11/201310/24/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E11/11/201310/24/2014
Labeler - Safetec of America, Inc. (874965262)

Revised: 12/2019
Document Id: bddc0707-7f8d-4204-918d-e588b79e8d92
Set id: 2d73f0d8-24dc-4866-b00f-54b31fbc4760
Version: 2
Effective Time: 20191205