B.CLEAN HAND SANITIZER- alcohol gel
Marque of Brands Americas, LLC

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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I dont want germs on my hands (gel)

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

Ethyl Alcohol 60% v/v

Purpose

Antiseptic

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.

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. If swallowed, get medical help or contact a Poison Control Center right away.

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

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

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

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

label

B.CLEAN HAND SANITIZER
alcohol gel

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/30/2020

Labeler - Marque of Brands Americas, LLC (081170908)

Name	Address	ID/FEI	Business Operations
Establishment
Marque of Brands Americas, LLC		081170908	manufacture(73978-001)