FDA.reportPublic FDA data

AU NATURAL ORGANICS HAND SANITIZER GEL alcohol gel

Manufacturer
Au Natural Organics Company
Effective date
2020-06-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:05

Label at a glance#

Producthand sanitizer
Active ingredientALCOHOL
Label structure10 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.

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Warnings

WARNINGS SECTION

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

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, hydrosol, rosemary oil, citrus reticulata seed oil, lemon oil, aloe, konjac , plant coloring, zinc sulfate,

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5mL NDC: 79297-020-05

5ml label5ml label5ml label front5ml label front

30mL NDC: 79297-020-01 30ml label30ml label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79297-020-012022-01-28C16284748780-1d6a99b39-aa5c-a426-e053-dadaa90af4c2AU NATURAL ORGANICS HAND SANITIZER GEL alcohol gel
79297-020-052022-01-28C16284748780-1d6a99b39-aa5c-a426-e053-dadaa90af4c2AU NATURAL ORGANICS HAND SANITIZER GEL alcohol gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79297-020-01hand sanitizer30 mL in 1 POUCHGEL301
79297-020-05hand sanitizer5 mL in 1 PACKETGEL51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79297-020HAND SANITIZER (ALCOHOL) GEL [AU NATURAL ORGANICS COMPANY]1Legacy NDC, 2 package rows20200626_a8b524e5-8675-525d-e053-2995a90ae4f5.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79297-02079297-020-01, 79297-020-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRUS RETICULATA FRUIT OIL25P9H3QU5EIACT
AMORPHOPHALLUS KONJAC FLOWER/STEM/TUBERQW0X0GJK24IACT
ALOEV5VD430YW9IACT
GLYCERINPDC6A3C0OXIACT
ZINC SULFATE89DS0H96TBIACT
HAMAMELIS VIRGINIANA FLOWER WATER222MYC9QUVIACT
ALCOHOL3K9958V90MACTIB
ROSEMARY OIL8LGU7VM393IACT
LEMON OILI9GRO824LLIACT

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
a8b52237-f429-2f65-e053-2a95a90ab58ba8b524e5-8675-525d-e053-2995a90ae4f52020-06-22WarningsExact identifier
spl id: a8b52237-f429-2f65-e053-2a95a90ab58b
spl set id: a8b524e5-8675-525d-e053-2995a90ae4f5

Reported adverse events (FAERS/openFDA)#

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