BALMA SEPTIC ANTISEPTIC HAND WASH- benzalkonium chloride soap

Balma Septic Antiseptic Hand Wash by

Drug Labeling and Warnings

Balma Septic Antiseptic Hand Wash by is a Otc medication manufactured, distributed, or labeled by Rochester Midland Corporation, ABC Compounding Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts Box OTC-Active Ingredient Section

Benzalkonium Chloride 2.5%

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

water, 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

INGREDIENTS AND APPEARANCE

BALMA SEPTIC ANTISEPTIC HAND WASH 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59503-6265
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	25.0 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)
DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
PEG-75 LANOLIN (UNII: 09179OX7TB)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59503-6265-2	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/09/2017
2	NDC: 59503-6265-6	2500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/09/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/09/2017

Labeler - Rochester Midland Corporation (002207041)

Registrant - ABC Compounding Co., Inc. (003284353)

Establishment
Name	Address	ID/FEI	Business Operations
ABC Compounding Co., Inc.		003284353	manufacture(59503-6265)