Hand Sanitizer

Manufacturer
KARSOF SYSTEMS LLC
Effective date
2020-07-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:22:43

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

elettaria cardamomum, azadirachta indica, syzygium aromaticum, cinnamomum camphora, aloe vera, phyllanthus emblica, carbomer, glycerin, hydrogen peroxide, purified water USP, rosa gallica, crocus sativus, coconut oil, olive oil

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785.41ml NDC 77160-308-01

11
946.353ml NDC 77160-308-02

22
473.176ml NDC 77160-308-03

33
236.588ml NDC 77160-308-05

55


118.294ml NDC 77160-308-06

66


59.1471ml NDC 77160-308-07

77


59.1471ml NDC 77160-308-08

88

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77160-308-01Hand Sanitizer3785.41 mL in 1 BOTTLEGEL3785.412
77160-308-02Hand Sanitizer946.353 mL in 1 BOTTLEGEL946.3532
77160-308-03Hand Sanitizer473.176 mL in 1 BOTTLEGEL473.1762
77160-308-05Hand Sanitizer236.588 mL in 1 BOTTLEGEL236.5882
77160-308-06Hand Sanitizer118.294 mL in 1 BOTTLEGEL118.2942
77160-308-07Hand Sanitizer59.1471 mL in 1 BOTTLEGEL59.14712
77160-308-08Hand Sanitizer59.1471 mL in 1 BOTTLEGEL59.14712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77160-308HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [KARSOF SYSTEMS LLC]2Legacy NDC, 7 package rows20200727_ab5384ac-33ba-2ca1-e053-2a95a90a5121.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77160-30877160-308-01, 77160-308-02, 77160-308-03, 77160-308-05, 77160-308-06, 77160-308-07, 77160-308-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
ab537628-1201-1edc-e053-2995a90a63b9ab5384ac-33ba-2ca1-e053-2a95a90a51212020-07-26WarningsExact identifier
spl id: ab537628-1201-1edc-e053-2995a90a63b9
spl set id: ab5384ac-33ba-2ca1-e053-2a95a90a5121

Reported adverse events (FAERS/openFDA)#

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