B.CLEAN HAND SANITIZER (FOAM)- alcohol gel

b.clean hand sanitizer (foam) by

Drug Labeling and Warnings

b.clean hand sanitizer (foam) by is a Otc medication manufactured, distributed, or labeled by Marque of Brands Americas, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

ACTIVE INGREDIENT

Benzalkonium Chloride

Purpose

Antimicrobial

DOSAGE & ADMINISTRATION

• Place enough product on hands to cover all surfaces. Rub hands together until dry
• Supervise children under 6 years of age when using this product to avoid swallowing.

INACTIVE INGREDIENT

Water (Aqua), Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol,Tocopheryl Acetate, Squalane, Dihydroxypropyl PEG-5 Linoleammonium Chloride, Disodium Laureth Sulfosuccinate, Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Sodium Methyl Cocoyl Taurate, Phenoxyethanol, Citric Acid, Fragrence

Warning

• Flammable, keep away from flame.
• For External Use Only.

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.

WHEN USING

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse throughly with water.

DO NOT USE

• in children less than 2 months of age
• on open skin wounds

STOP USE

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

OTHER SAFETY INFORMATION

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

B.CLEAN HAND SANITIZER (FOAM) 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73978-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYPROPYL PEG-5 LINOLEAMMONIUM CHLORIDE (UNII: 0Y0NQR2GH1)
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SQUALANE (UNII: GW89575KF9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73978-002-01	29 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 73978-002-02	177 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
3	NDC: 73978-002-03	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Marque of Brands Americas, LLC (081170908)

Establishment
Name	Address	ID/FEI	Business Operations
Marque of Brands Americas, LLC		081170908	manufacture(73978-002)