Purevita 80% Hand Sanitizer Gel

Manufacturer
Davita Chemicals, LLC
Effective date
2020-06-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:18:17

Label at a glance#

ProductPurevita 80% Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure27 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

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 (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  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)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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 SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59 ML Label59 ML Label059 mL NDC: 78677-800-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

118 ML Label118 ML Label118 mL NDC: 78677-800-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

177 ML Label177 ML Label177 mL NDC: 78677-800-06

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

236 ML Label236 ML Label236 mL NDC: 78677-800-08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

295 ML Label295 ML Label295mL NDC: 78677-800-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

354 ML Label354 ML Label354 mL NDC: 78677-800-12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

473 Ml Label473 Ml Label473 mL NDC: 78677-800-16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

709 ML Label709 ML Label709 mL NDC: 78677-800-24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

946 Ml Label946 Ml Label946 mL NDC: 78677-800-32

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1892 Ml Label1892 Ml Label1892 mL NDC: 78677-800-64

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3875 ML Label3875 ML Label3875 mL NDC: 78677-800-70

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

113562 ML Label113562 ML Label113562 mL NDC: 78677-800-73

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

208198 ML Label208198 ML Label208198 mL NDC: 78677-800-75

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

124919 ML Label124919 ML Label124919 mL NDC: 78677-800-83

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2271247 ML label2271247 ML label2271247 mL NDC: 78677-800-99

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN2
1041498ethanol 0.8 ML/ML Topical GelSCD2
1041498ethanol 80 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78677-800-022022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-042022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-062022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-082022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-102022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-122022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-162022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-242022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-322022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-642022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-702022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-712022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-732022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-752022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-832022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd
78677-800-992022-01-28C16284748780-1d6a99b39-c2ee-a426-e053-dadaa90af4c2a710ef17-cbde-5e97-e053-2a95a90a65bd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78677-800-02Purevita 80% Hand Sanitizer Gel59 mL in 1 BOTTLE, DISPENSINGGEL592
78677-800-04Purevita 80% Hand Sanitizer Gel118 mL in 1 BOTTLE, DISPENSINGGEL1182
78677-800-06Purevita 80% Hand Sanitizer Gel177 mL in 1 BOTTLE, DISPENSINGGEL1772
78677-800-08Purevita 80% Hand Sanitizer Gel236 mL in 1 BOTTLE, DISPENSINGGEL2362
78677-800-10Purevita 80% Hand Sanitizer Gel295 mL in 1 BOTTLE, DISPENSINGGEL2952
78677-800-12Purevita 80% Hand Sanitizer Gel354 mL in 1 BOTTLE, DISPENSINGGEL3542
78677-800-16Purevita 80% Hand Sanitizer Gel473 mL in 1 BOTTLE, DISPENSINGGEL4732
78677-800-24Purevita 80% Hand Sanitizer Gel709 mL in 1 BOTTLE, DISPENSINGGEL7092
78677-800-32Purevita 80% Hand Sanitizer Gel946 mL in 1 BOTTLE, DISPENSINGGEL9462
78677-800-64Purevita 80% Hand Sanitizer Gel1892 mL in 1 BOTTLE, DISPENSINGGEL18922
78677-800-70Purevita 80% Hand Sanitizer Gel3785 mL in 1 JUGGEL37852
78677-800-71Purevita 80% Hand Sanitizer Gel3785 mL in 1 BOX, UNIT-DOSEGEL37852
78677-800-73Purevita 80% Hand Sanitizer Gel11356 mL in 1 DRUMGEL113562
78677-800-75Purevita 80% Hand Sanitizer Gel208198 mL in 1 DRUMGEL2081982
78677-800-83Purevita 80% Hand Sanitizer Gel124919 mL in 1 DRUMGEL1249192
78677-800-99Purevita 80% Hand Sanitizer Gel2271247 mL in 1 TANKGEL22712472

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78677-800PUREVITA 80% HAND SANITIZER GEL (ETHYL ALCOHOL) GEL [DAVITA CHEMICALS, LLC]2Legacy NDC, 16 package rows20200619_a710ef17-cbde-5e97-e053-2a95a90a65bd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a865d212-caed-6388-e053-2a95a90a4563a710ef17-cbde-5e97-e053-2a95a90a65bd2020-06-18WarningsExact identifier
spl id: a865d212-caed-6388-e053-2a95a90a4563
spl set id: a710ef17-cbde-5e97-e053-2a95a90a65bd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.