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 (1.45% v/v).
Hydrogen peroxide (0.125% v/v).
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 80% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

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

Warnings

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

Do not use

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

When using this product 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 occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Directions

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.

Other information

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

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

59 ML Label 059 mL NDC: 78677-800-02

118 ML Label 118 mL NDC: 78677-800-04

177 ML Label 177 mL NDC: 78677-800-06

236 ML Label 236 mL NDC: 78677-800-08

295 ML Label 295mL NDC: 78677-800-10

354 ML Label 354 mL NDC: 78677-800-12

473 Ml Label 473 mL NDC: 78677-800-16

709 ML Label 709 mL NDC: 78677-800-24

946 Ml Label 946 mL NDC: 78677-800-32

1892 Ml Label 1892 mL NDC: 78677-800-64

3875 ML Label 3875 mL NDC: 78677-800-70

113562 ML Label 113562 mL NDC: 78677-800-73

208198 ML Label 208198 mL NDC: 78677-800-75

124919 ML Label 124919 mL NDC: 78677-800-83

2271247 ML label 2271247 mL NDC: 78677-800-99

PUREVITA 80% HAND SANITIZER GEL
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78677-800
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 mL in 100 mL
WATER (UNII: 059QF0KO0R)	18.425 mL in 100 mL

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78677-800-02	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/07/2020
2	NDC:78677-800-04	118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/07/2020
3	NDC:78677-800-06	177 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/07/2020
4	NDC:78677-800-08	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/07/2020
5	NDC:78677-800-10	295 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/07/2020
6	NDC:78677-800-12	354 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/07/2020
7	NDC:78677-800-16	473 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/07/2020
8	NDC:78677-800-24	709 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/07/2020
9	NDC:78677-800-32	946 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/07/2020
10	NDC:78677-800-64	1892 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	03/07/2020
11	NDC:78677-800-70	3785 mL in 1 JUG; Type 0: Not a Combination Product	03/07/2020
12	NDC:78677-800-73	11356 mL in 1 DRUM; Type 0: Not a Combination Product	03/07/2020
13	NDC:78677-800-75	208198 mL in 1 DRUM; Type 0: Not a Combination Product	03/07/2020
14	NDC:78677-800-83	124919 mL in 1 DRUM; Type 0: Not a Combination Product	03/07/2020
15	NDC:78677-800-99	2271247 mL in 1 TANK; Type 0: Not a Combination Product	03/07/2020
16	NDC:78677-800-71	3785 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product	03/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/07/2020

Labeler - Davita Chemicals, LLC (117478480)

Name	Address	ID/FEI	Business Operations
Establishment
Davita Chemicals, LLC		117478480	manufacture(78677-800) , relabel(78677-800) , repack(78677-800) , label(78677-800)