B.CLEAN HAND SANITIZER- alcohol gel

b.clean hand sanitizer by

Drug Labeling and Warnings

b.clean hand sanitizer 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

Ethyl Alcohol 60% v/v

Purpose

Antiseptic

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, Carbomer, Fragrance, Glycerin, Propylene Glycol,Tocopheryl Acetate, Squalane

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

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 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73978-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	60 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
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: 73978-001-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2020
2	NDC: 73978-001-02	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
3	NDC: 73978-001-03	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
4	NDC: 73978-001-04	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(73978-001)