Ultracare For Hands

Dosage form: liquid
Ingredients: BENZALKONIUM CHLORIDE 1mg in 1mL
Labeler: Coltene Whaledent Inc
NDC Code: 51614-0001

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

Benzalkonium Chloride 0.1%

Purpose

Antimicrobial

Use hand sanitizer to reduce bacteria on the skin.

Warnings

For external use only

When using this product avoid contact with eyes.

In case of eye contact, flush with water.

Stop use and ask a doctor if irritation or redness develops, or if condition 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 enough product in palm to thoroughly cover all surfaces of both hands

Rub hands together briskly until dry

No rinsing required

Inactive Ingredients

Water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid

Ultracare

For Hands

Alcohol Free Antiseptic Handwash

Formulated to reduce the number of germs on the hands that can cause infection and illness.

Use on clean, non-soiled hands any time when rinsing with water is not available.

Alcohol free, so it can be used in any area without fear of it creating a flammable atmosphere.

Manufactured for

Ultronics

Cuyahoga Falls, OH 44223

www.UltronicsUSA.com  Tel. (800) 262-6262

1000 ml  33.8 fl. oz.  Made in USA  P/N

ULTRACARE FOR HANDS 
benzalkonium chloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51614-0001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CETRIMONIUM CHLORIDE 
LAURTRIMONIUM CHLORIDE 
DIHYDROXYETHYL COCAMINE OXIDE 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:51614-0001-11000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/22/2012
Labeler - Coltene Whaledent Inc (622185718)
Establishment
NameAddressID/FEIOperations
Woodbine Products Company004220323manufacture

Revised: 06/2012
 
Coltene Whaledent Inc

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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