FDA.reportPublic FDA data

Advanced Hand Sanitizer Gel

Manufacturer
Sanare Bioscience
Effective date
2020-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:36:11

Label at a glance#

ProductAdvanced Hand Sanitizer Gel
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

Wet hands thoroughly with product, and allow to dry without wiping. For children under six, use only under adult supervision

Storage and handling

Store between 15-30C. Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics

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 70% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

For hand washing to decrease bacteria on the skin –recommended for repeated use

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

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 occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help immediately or contact a Poison Control Center immediately

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

  • Wet hands thoroughly with product, and allow to dry without wiping. For children under six, use only under adult supervision

Other information

STORAGE AND HANDLING SECTION

Store between 15-30C. Avoid freezing and excessive heat above 40C (104F). May discolor some fabrics. Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified water, hydrogen peroxide, and glycerin , Carbomer

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package.Label Principal Display PanelPackage.Label Principal Display Panel236 mL NDC: 78515-002-08

or

3785 mL NDC - 78515-002-28

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN4
581662ethanol 0.7 ML/ML Topical GelSCD4
581662ethanol 70 % Topical GelSY4
581662ethyl alcohol 70 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78515-002-082022-01-28C16284748780-1d6a99b39-67a5-a426-e053-dadaa90af4c2a7bc1be4-e7bc-fdfb-e053-2a95a90ac739
78515-002-282022-01-28C16284748780-1d6a99b39-67a5-a426-e053-dadaa90af4c2a7bc1be4-e7bc-fdfb-e053-2a95a90ac739
78515-002-322022-01-28C16284748780-1d6a99b39-67a5-a426-e053-dadaa90af4c2a7bc1be4-e7bc-fdfb-e053-2a95a90ac739

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78515-002-08Advanced Hand Sanitizer Gel236 mL in 1 BOTTLE, PLASTICGEL2364
78515-002-28Advanced Hand Sanitizer Gel3785 mL in 1 BOTTLE, PLASTICGEL37854
78515-002-32Advanced Hand Sanitizer Gel946 mL in 1 BOTTLE, PLASTICGEL9464

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78515-002ADVANCED HAND SANITIZER GEL (ALCOHOL) GEL [SANARE BIOSCIENCE]4Legacy NDC, 3 package rows20201231_a7bc1be4-e7bc-fdfb-e053-2a95a90ac739.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78515-00278515-002-08, 78515-002-28, 78515-002-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S)T967IEU43CIACT

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
b7af2d54-f25d-5151-e053-2995a90a91d2a7bc1be4-e7bc-fdfb-e053-2a95a90ac7392020-12-30WarningsExact identifier
spl id: b7af2d54-f25d-5151-e053-2995a90a91d2
spl set id: a7bc1be4-e7bc-fdfb-e053-2a95a90ac739

Reported adverse events (FAERS/openFDA)#

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