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Balma Septic Antiseptic Hand Wash

Medically reviewed on May 9, 2017

Dosage form: soap
Ingredients: BENZALKONIUM CHLORIDE 25.0mg in 1mL
Labeler: Rochester Midland Corporation
NDC Code: 59503-6265

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.

Balma Septic Antiseptic Hand Wash 6265 Drug Facts and Label

Drug Facts Box OTC-Active Ingredient Section

Chloroxylenol 0.3%

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

for hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

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
  • wet hands and forearms
  • apply 5 milliliters (teaspoonful) or palmful to hands and forearms
  • scrub thoroughly for 1 minute and rinse

Drug Facts Box OTC-Inactive Ingredient Section

ater, glycerin, isopropyl alcohol, disodium cocoamphodiproprionate, hydroxyethylcellulose, lauramine oxide,

PEG-75 lanolin, citric acid, FD and C red no.4

Balm Septic Antiseptic Handwash 6265

Balm Septic Antiseptic Handwash 6265

BALMA SEPTIC ANTISEPTIC HAND WASH 
benzalkonium chloride soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59503-6265
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE25.0 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ISOPROPYL ALCOHOL 
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) 
DISODIUM COCOAMPHODIPROPIONATE 
LAURAMINE OXIDE 
PEG-75 LANOLIN 
GLYCERIN 
CITRIC ACID MONOHYDRATE 
FD&C RED NO. 4 
Packaging
#Item CodePackage Description
1NDC:59503-6265-23785 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/09/2017
Labeler - Rochester Midland Corporation (002207041)
Registrant - ABC Compounding Co., Inc. (003284353)
Establishment
NameAddressID/FEIOperations
ABC Compounding Co., Inc.003284353manufacture(59503-6265)

 
Rochester Midland Corporation

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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