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Instant Hand Sanitizer by Safetec of America, Inc.

Medically reviewed on March 22, 2018

Dosage form: gel
Ingredients: alcohol 665mL in 1L
Labeler: Safetec of America, Inc.
NDC Code: 61010-1112

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 Ingredients

Ethyl Alcohol 66.5%

Purpose

Antiseptic

Uses
  • for handwashing to decrease bacteria on skin without soap and water
  • recommended for repeated use

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 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
  • wet hands & wrists thoroughly with product
  • allow to dry without wiping
  • children under 6 should be supervised while using this product

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 – 4 fl. oz. Bottle Label

NDC 61010-1112-5

Safetec

instant

Hand

Sanitizer

Kills 99.9% of Germs

Enriched with

Aloe Vera

Fresh

4.0 FL. OZ. (118 ML)

INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-1112
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
alcohol (alcohol) alcohol665 mL  in 1 L
Inactive Ingredients
Ingredient NameStrength
aloe vera leaf 
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
D&C GREEN NO. 5 
d&c yellow no. 10 
water 
trolamine 
Packaging
#Item CodePackage Description
1NDC:61010-1112-5.118 L in 1 BOTTLE
2NDC:61010-1112-6.237 L in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/22/2012
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE(61010-1112)

 
Safetec of America, Inc.

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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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