MANDARIN SCENT ANTI BACTERIAL HAND SOAP 13OZ

BENZALKONIUM CHLORIDE by

Drug Labeling and Warnings

BENZALKONIUM CHLORIDE by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc., LAB DOUCE BIOTECHNOLOGY HUIZHOU LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BENZALKONIUM CHLORIDE- benzalkonium chloride gel 
Greenbrier International, Inc.

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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MANDARIN SCENT ANTI BACTERIAL HAND SOAP 13OZ

Drug Facts

Active Ingredient

Benzalkonium chloride 0.12%

Purpose



Antibacterial

Uses

• For handwashing to decrease bacterial on the skin

Warnings

For external use only.

When using this product avoid contact with eyes. In case of eye contact, fluse with water.

Stop use and ask a doctor if  irritation or redness develop.

Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Directions

• Pump into hands, wet as need.
• Lather vigorously for at least 15 seconds
• Wash skin, rinse thoroughly and dry.

Inactive Ingredients







water, sodium laureth sulfate, cocamide methyl MEA, sodium chloride, peg-150 distearate, fragrance, citric acid, methylisothiazolinone, red 40, yellow 5, blue 1

DISTRIBUTED BY:

GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

MADE IN CHINA

MANDARIN SCENT ANTI BACTERIAL HAND SOAP

BENZALKONIUM CHLORIDE 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-8989
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
LAURIC MONOETHANOLAMIDE (UNII: 098P2IGT76)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-150 STEARATE (UNII: 7BSG7DF10Q)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	orange	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 33992-8989-1	369 g in 1 BOTTLE; Type 0: Not a Combination Product	08/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	08/25/2020	04/30/2021

Labeler - Greenbrier International, Inc. (610322518)

Establishment
Name	Address	ID/FEI	Business Operations
LAB DOUCE BIOTECHNOLOGY HUIZHOU LTD		554425078	manufacture(33992-8989)

Revised: 4/2021

Document Id: c30d97ab-88ba-72ea-e053-2a95a90a1366

34390-5

Set id: adf3be1e-8d88-7dcc-e053-2995a90a97a4

Version: 3

Effective Time: 20210430