B4 ANTISEPTIC HAND SANITIZER- benzalkonium chloride gel

B4 Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

B4 Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Ming Fai Industrial (Shenzhen) Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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, ethylhexylglycerin, fragrance, glyceri, phenoxyethanol, sodium lauryl sulfate, water.

Package Labeling:

INGREDIENTS AND APPEARANCE

B4 ANTISEPTIC HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56153-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	13 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56153-500-00	15 mL in 1 TUBE; Type 0: Not a Combination Product	06/21/2017
2	NDC: 56153-500-01	500 in 1 BOX	06/21/2017
2		15 mL in 1 TUBE; 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	06/21/2017

Labeler - Ming Fai Industrial (Shenzhen) Co. Ltd (527078784)

Registrant - Ming Fai Industrial (Shenzhen) Co. Ltd (527078784)

Establishment
Name	Address	ID/FEI	Business Operations
Ming Fai Industrial (Shenzhen) Co. Ltd		527078784	manufacture(56153-500)