B4 ANTISEPTIC HAND SANITIZER- benzalkonium chloride gel
Ming Fai Industrial (Shenzhen) Co. Ltd

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.

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B4 Antiseptic Hand Sanitizer Gel

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:

box Inner Label1

B4 ANTISEPTIC HAND SANITIZER
benzalkonium chloride gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56153-500-00	15 mL in 1 TUBE; Type 0: Not a Combination Product	06/21/2017	12/31/2020
2	NDC:56153-500-01	500 in 1 BOX	06/21/2017	12/31/2020
2		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/21/2017	12/31/2020

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

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

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

Revised: 1/2021

Document Id: b814ff7a-86db-9515-e053-2995a90a73d7

Set id: 4bbb949b-bd37-2868-e054-00144ff88e88

Version: 7

Effective Time: 20210104

Ming Fai Industrial (Shenzhen) Co. Ltd