FDA Label for Hello Bello Hand Sanitizer
View Indications, Usage & Precautions
Hello Bello Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Brands International Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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:
- 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.
- Glycerol
- Hydrogen peroxide
- 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
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - 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
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