HELLO BELLO HAND SANITIZER- alcohol gel

Hello Bello Hand Sanitizer by

Drug Labeling and Warnings

Hello Bello Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Brands International Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol
3. Hydrogen peroxide
4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

Alcohol 75% v/v

Purpose

Antiseptic Skin Cleanser

Use

Antiseptic (skin) Cleanser

Warnings

For external use only. Flammable. Keep away from heat or flame

Do not use

Children adolescents and adults 2 years and over

Other information

• Store below 43 degree Celcius/ 100 degree F
• May discolor certain fabrics or surfaces

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, 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

• Place enough product on your palm to thoroughly cover your hands.
• Rub thoroughly into hands for at least 30 seconds. Allow to dry

Inactive ingredients

Glycerin, Water, Isopropyl Alcohol, Propylene Glycol, Tocopherol Acetate (Vitamin E), Aloe Barbadensis Leaf Extract, Carbomer, Aminomethyl Propanol, Parfum

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

HELLO BELLO HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-225
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-225-10	1000 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	12/23/2021

Labeler - Brands International Corporation (243748238)

Registrant - Brands International Corporation (243748238)