BELLA VITA ADVANCED HAND SANITIZER- isopropyl alcohol gel
EPOCH Cosmetics and Toiletries Industries 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. 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 ELEGANT.

Other information

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

Inactive ingredients

Water (Aqua), Isopropyl Alchohol, Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/ C10-30 Alkyl Acrylate Corssploymer, Aminomethyl Propanol, Fragrance (Parfum).

Package Label - Principal Display Panel

label label 2 label 3 label 4 label 5 label 6

BELLA VITA ADVANCED HAND SANITIZER
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:80309-005
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
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:80309-005-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
2	NDC:80309-005-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020
3	NDC:80309-005-03	250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
4	NDC:80309-005-04	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
5	NDC:80309-005-06	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	03/30/2020
6	NDC:80309-005-07	2000 mL in 1 BOTTLE; 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 - EPOCH Cosmetics and Toiletries Industries LLC (561196517)

Name	Address	ID/FEI	Business Operations
Establishment
EPOCH Cosmetics and Toiletries Industries LLC		561196517	manufacture(80309-005)