BELLA VITA HAND SANITIZER- isopropyl alcohol spray
Porto Pavino 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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Active Ingredient(s)

Isopropyl Alcohol 70%

Purpose

Antimicrobial

Use

Hand Sanitizer to help reduce bacteria on the skin.

Warnings

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

When using this product do not use in or near the eyes. keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash and lasts.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Put enough product in your palm to cover hands and rub hands together briskly until dry
Children under 6 years of age be supervised when using BELLAVITA.

Other information

Store between 110F (43C)
May discolor certain fabrics

Inactive ingredients

Water (Aqua), Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myrstate, Tocopheryly Acetate, Acrylates/ C 10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum).

Package Label - Principal Display Panel

label label 2 label 3 label 4

BELLA VITA HAND SANITIZER
isopropyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:90012-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:90012-007-01	20 mL in 1 BOTTLE, SPRAY; 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 - Porto Pavino LLC (966266434)

Name	Address	ID/FEI	Business Operations
Establishment
EPOCH Cosmetics and Toiletries Industries LLC		561196517	manufacture(90012-007)