FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Archroma Pakistan Limited
Effective date
2021-03-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:12

Label at a glance#

ProductHand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure13 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. 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.
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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5000 ml NDC: 81620-250-10

5000 ml5000 ml

50 ml NDC: 81620-250-05

50 ml front50 ml front

50 ml50 ml

120 ml NDC: 81620-250-06

250 ml NDC: 81620-250-07

250 ml front250 ml front

250 ml back250 ml back

500 ml NDC: 81620-250-08

500 ml500 ml

5000 ml back5000 ml back

1000 ml NDC: 81620-250-09

1000 ml front1000 ml front

1000 ml1000 ml

60000 ml NDC: 81620-250-11

200000 ml NDC: 81620-250-12

1000000 ml NDC: 81620-250-13

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138960101310052GTIN-13: 8960101310052
EAN-13: 8960101310052
GTIN storage (14 digits): 08960101310052		COSYN Original 500 ml Label-2.jpg
BarcodeEAN-138960101310069GTIN-13: 8960101310069
EAN-13: 8960101310069
GTIN storage (14 digits): 08960101310069		COSYN Original1L Label-2.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81620-250-052022-07-29C16284748780-1e4f33bdf-9f1b-d8a0-e053-dadaa90a6e4eHand Sanitizer
81620-250-062022-07-29C16284748780-1e4f33bdf-9f1b-d8a0-e053-dadaa90a6e4eHand Sanitizer
81620-250-072022-07-29C16284748780-1e4f33bdf-9f1b-d8a0-e053-dadaa90a6e4eHand Sanitizer
81620-250-082022-07-29C16284748780-1e4f33bdf-9f1b-d8a0-e053-dadaa90a6e4eHand Sanitizer
81620-250-092022-07-29C16284748780-1e4f33bdf-9f1b-d8a0-e053-dadaa90a6e4eHand Sanitizer
81620-250-102022-07-29C16284748780-1e4f33bdf-9f1b-d8a0-e053-dadaa90a6e4eHand Sanitizer
81620-250-112022-07-29C16284748780-1e4f33bdf-9f1b-d8a0-e053-dadaa90a6e4eHand Sanitizer
81620-250-122022-07-29C16284748780-1e4f33bdf-9f1b-d8a0-e053-dadaa90a6e4eHand Sanitizer
81620-250-132022-07-29C16284748780-1e4f33bdf-9f1b-d8a0-e053-dadaa90a6e4eHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81620-250-05Hand Sanitizer50 mL in 1 BOTTLESOLUTION/ DROPS501
81620-250-06Hand Sanitizer120 mL in 1 BOTTLESOLUTION/ DROPS1201
81620-250-07Hand Sanitizer250 mL in 1 BOTTLESOLUTION/ DROPS2501
81620-250-08Hand Sanitizer500 mL in 1 BOTTLESOLUTION/ DROPS5001
81620-250-09Hand Sanitizer1000 mL in 1 BOTTLESOLUTION/ DROPS10001
81620-250-10Hand Sanitizer5000 mL in 1 CANSOLUTION/ DROPS50001
81620-250-11Hand Sanitizer60000 mL in 1 CANSOLUTION/ DROPS600001
81620-250-12Hand Sanitizer200000 mL in 1 DRUMSOLUTION/ DROPS2000001
81620-250-13Hand Sanitizer1000000 mL in 1 DRUMSOLUTION/ DROPS10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81620-250HAND SANITIZER (ISOPROPYL ALCOHOL) SOLUTION/ DROPS [ARCHROMA PAKISTAN LIMITED]1Legacy NDC, 9 package rows20210326_be6a7b68-f1fa-4fed-e053-2995a90a9486.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
81620-25081620-250-05, 81620-250-06, 81620-250-07, 81620-250-08, 81620-250-09, 81620-250-10, 81620-250-11, 81620-250-12, 81620-250-13

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

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
be6a75b3-82dc-109c-e053-2a95a90aee17be6a7b68-f1fa-4fed-e053-2995a90a94862021-03-26WarningsExact identifier
spl id: be6a75b3-82dc-109c-e053-2a95a90aee17
spl set id: be6a7b68-f1fa-4fed-e053-2995a90a9486

Reported adverse events (FAERS/openFDA)#

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