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Hand Sanitizer by Rochester Midland Corporation

Dosage form: liquid
Ingredients: ALCOHOL 0.62mL in 1mL
Labeler: Rochester Midland Corporation
NDC Code: 59503-6585

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.

Hand Sanitizer 6585 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Ethyl Alcohol 62% v/v

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

FLAMMABLE, keep away from fire and flames

For external use only

Drug Facts Box OTC-When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

if swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box OTC-Dosage & Administration Section

press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

rub hands together and allow to dry without wiping

Drug Facts Box OTC-Inactive Ingredient Section

water, DEA-C8-18 perfluoroalkylethyl phosphate, propylene glycol, fragrance

Hand Sanitizer 6585 650 ml bag

6585B6P5488.jpg  Hand Sanitizer  650 ml bag 

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59503-6585
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL0.62 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
DIETHANOLAMINE BIS(C8-C18 PERFLUOROALKYLETHYL)PHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:59503-6585-9650 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E09/23/2011
Labeler - Rochester Midland Corporation (002207041)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIOperations
ABC Compounding Co., Inc.003284353manufacture

Revised: 09/2011
 
Rochester Midland Corporation

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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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