B4 ANTISEPTIC HAND SANITIZER BENZALKONIUM CHLORIDE 0.13%- benzalkonium chloride gel

b4 Antiseptic Hand Sanitizer Benzalkonium Chloride 0.13% by

Drug Labeling and Warnings

b4 Antiseptic Hand Sanitizer Benzalkonium Chloride 0.13% by is a Otc medication manufactured, distributed, or labeled by Midway Advanced Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium chloride 0.13%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin.

Warnings

​For external use only

​Do not use​

• in the eyes

​Stop use and ask a doctor if

• irritation and redness develop
• if condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping

Other information

store at room temperature

Inactive ingredients

butylene glycol, caesalpinia spinosa gum, citric acid, ethylhexylgycerin, fragrance, glycerin, phenoxyethanol, sodium lauryl sulfate, water

Package Labeling:

INGREDIENTS AND APPEARANCE

B4 ANTISEPTIC HAND SANITIZER BENZALKONIUM CHLORIDE 0.13% 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52490-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52490-500-15	15 mL in 1 TUBE; Type 0: Not a Combination Product	05/15/2017	06/13/2020
2	NDC: 52490-500-20	500 in 1 CARTON	05/15/2017	06/13/2020
2		15 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 52490-500-01	0.7 mL in 1 PACKAGE; Type 0: Not a Combination Product	02/01/2018	07/13/2020
4	NDC: 52490-500-16	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018	02/05/2020
5	NDC: 52490-500-21	100 in 1 CARTON	02/01/2018	02/05/2020
5		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC: 52490-500-31	2000 in 1 CARTON	02/01/2018	06/08/2020
6		0.7 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/15/2017	07/13/2020

Labeler - Midway Advanced Products LLC (962765009)