Hand Sanitizer

Manufacturer
Balm of Gilead
Effective date
2020-06-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:18:53

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
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

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.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% 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

citrus aurantium bergamia (bergamot) peel oil, glycerin, hydrogen peroxide, purified water USP, zingiber officinale (ginger) root oil

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1892ml Label - Balm of Gilead1892ml Label - Balm of Gilead30ml Label30ml Label60ml Label Cocobee.co60ml Label Cocobee.co

59ml Label - Balm of Gilead59ml Label - Balm of Gilead

3785ml Label - Cocobee.co3785ml Label - Cocobee.co

3785ml Label - Balm of Gilead3785ml Label - Balm of Gilead

208198ml Label208198ml Label

1040988ml Label1040988ml Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN3
1039339ethanol 0.8 ML/ML Topical SolutionSCD3
1039339ethanol 80 % Topical SolutionSY3

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74843-2627-1Hand Sanitizer30 mL in 1 BOTTLE, SPRAYLIQUID303
74843-2627-2Hand Sanitizer59 mL in 1 BOTTLE, SPRAYLIQUID593
74843-2627-3Hand Sanitizer3785 mL in 1 JUGLIQUID37853
74843-2627-4Hand Sanitizer208198 mL in 1 DRUMLIQUID2081983
74843-2627-5Hand Sanitizer1040988 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID10409883
74843-2627-6Hand Sanitizer1892 mL in 1 JUGLIQUID18923

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74843-2627HAND SANITIZER (ALCOHOL) LIQUID [BALM OF GILEAD]3Legacy NDC, 6 package rows20200625_a53e3924-c26e-ea47-e053-2995a90a222a.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74843-262774843-2627-3, 74843-2627-1, 74843-2627-2, 74843-2627-4, 74843-2627-5, 74843-2627-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
a8dbd78e-64bf-3d06-e053-2995a90ad256a53e3924-c26e-ea47-e053-2995a90a222a2020-06-24WarningsExact identifier
spl id: a8dbd78e-64bf-3d06-e053-2995a90ad256
spl set id: a53e3924-c26e-ea47-e053-2995a90a222a

Reported adverse events (FAERS/openFDA)#

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