ANTIBACTERIAL WASHING HAND- benzalkonium chloride soap

ANTIBACTERIAL washing HAND by

Drug Labeling and Warnings

ANTIBACTERIAL washing HAND by is a Otc medication manufactured, distributed, or labeled by PurCel Labs LLC, ZHEJIANG QIMEI COSMETICS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.2% v/v

Purpose

Antiseptic

Uses

For hand-washing to decrease bacteria on the skin.

Warnings

For external use only.

WHEN USING

When using this product do not use in or near the eyes. In case of contact rinse eyes thoroughly with water.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Directions

Wet hands and forearms.
Apply 5 milliliters (teaspoonful) or palmful to hands and forearms.
Scrub thoroughly for 1 minute and rinse.

Inactive ingredients

Water, Cocamidopropyl Betaine, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Glycerin, Sodium
Chloride, Aloe Barbadensis Extract, Phenoxyethanol, Sodium Benzoate, Parfum, Citric Acid.

Package label.principal display panel

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL WASHING HAND 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83584-524
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
CITRIC ACID (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83584-524-03	6 in 1 CARTON	01/01/2025
1	NDC: 83584-524-02	2 in 1 BOX
1	NDC: 83584-524-01	1400 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	01/01/2025

Labeler - PurCel Labs LLC (127672531)

Establishment
Name	Address	ID/FEI	Business Operations
ZHEJIANG QIMEI COSMETICS CO., LTD.		709887693	manufacture(83584-524)