FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
NOORANI TRADING INC. | NOORANI TRADING INC
Effective date
2020-05-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:11:32

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure21 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. If swallowed, get medical help or contact poison center right way.

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. Isopropyl Alcohol (75%, 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

Isopropyl Alcohol 75% 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation, rednedd or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep away from Children & pets.

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. If swallowed, get medical help or contact poison center right way.

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

70 ml NDC: 77320-786-70

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70 ml LABEL70 ml LABEL70 ml NDC: 77320-786-70

70 ml BOTTLE FRONT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70 ml BOTTLE FRONT70 ml BOTTLE FRONT70 ml NDC: 77320-786-70

70 ml BOTTLE BACK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70ml BOTTLE BACK70ml BOTTLE BACK70 ml NDC: 77320-786-70

540 ml LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

540 ml LABEL540 ml LABEL540 ML NDC: 77320-786-18

540 ml BOTTLE FRONT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

540 ml BOTTLE FRONT540 ml BOTTLE FRONT540 ml NDC: 77320-786-18

540 ml BOTTLE BACK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

540 ml BOTTLE BACK540 ml BOTTLE BACK540 ml NDC: 77320-786-18

3840 ml LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3840 ml LABEL3840 ml LABEL3840 ml NDC: 77320-786-01

3840 ml GALLON FRONT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3840 ml GALLON FRONT3840 ml GALLON FRONT3840 ml NDC: 77320-786-01

3840 ml GALLON BACK

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3840 ml GALLON BACK3840 ml GALLON BACK3840 ml NDC : 77320-786-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN1
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD1
1039900isopropyl alcohol 75 % Topical SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77320-786-012022-01-28C16284748780-1d6a99b39-a525-a426-e053-dadaa90af4c2HAND SANITIZER
77320-786-182022-01-28C16284748780-1d6a99b39-a525-a426-e053-dadaa90af4c2HAND SANITIZER
77320-786-702022-01-28C16284748780-1d6a99b39-a525-a426-e053-dadaa90af4c2HAND SANITIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77320-786-01Hand Sanitizer3840 mL in 1 BOTTLELIQUID38401
77320-786-18Hand Sanitizer540 mL in 1 BOTTLELIQUID5401
77320-786-70Hand Sanitizer70 mL in 1 BOTTLELIQUID701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77320-786HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [NOORANI TRADING INC.]1Legacy NDC, 3 package rows20200515_a5615d8b-8836-39b1-e053-2a95a90af214.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77320-78677320-786-70, 77320-786-01, 77320-786-18

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

Source Document#

Source XML · Source PDF

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
a5614f5a-32a3-0b1e-e053-2995a90a0243a5615d8b-8836-39b1-e053-2a95a90af2142020-05-15WarningsExact identifier
spl id: a5614f5a-32a3-0b1e-e053-2995a90a0243
spl set id: a5615d8b-8836-39b1-e053-2a95a90af214

Reported adverse events (FAERS/openFDA)#

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