Balma Septic Antiseptic Hand Wash (Benzalkonium Chloride) Soap [Rochester Midland Corporation] -

BALMA SEPTIC ANTISEPTIC HAND WASH (BENZALKONIUM CHLORIDE) SOAP [ROCHESTER MIDLAND CORPORATION]
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NDC	59503-6265-2
Set ID	1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528
Category	HUMAN OTC DRUG LABEL
Packager	Rochester Midland Corporation
Generic Name
Product Class
Product Number
Application Number	PART333E

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/09/2017

Labeler - Rochester Midland Corporation (002207041)

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

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

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