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Instant Hand Sanitizer by APEX Sanitation, LLC

Medically reviewed on March 27, 2018

Dosage form: gel
Ingredients: alcohol 540.26g in 1L
Labeler: APEX Sanitation, LLC
NDC Code: 57685-7110

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.

Drug Facts

Active ingredient

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on skin without soap and water.

Warnings

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

Keep out of reach of children.

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

Stop use, ask doctor if irritation develops and persists for 72 hours. If ingested, get medical help or contact a Poison Control Center right away.

Directions
  • wet hands & wrists thoroughly with product and allow to dry without wiping

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL – Pouch

NDC 57685-7110-0

APEX

ANTISEPTIC

Instant Hand

Sanitizer

Fresh Scent
with Aloe Vera

0.0570 fl.oz. (1.68 mL)

MFD for APEX SANITATION, LLC.

Detroit, MI 48228 800-281-1878

www.ApexAntiseptic.com

INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57685-7110
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
alcohol (alcohol) alcohol540.26 g  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
d&c green no. 5 
d&c yellow no. 10 
water 
trolamine 
Packaging
#Item CodePackage Description
1NDC:57685-7110-00.00168 L in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/27/2013
Labeler - APEX Sanitation, LLC (078776562)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(57685-7110)

 
APEX Sanitation, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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