FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
One Up Manufacturing LLC
Effective date
2020-04-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:07:09

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

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 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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15 mL NDC: 75518-111-01 One Up Hand Sanitizer 15ml Full LabelOne Up Hand Sanitizer 15ml Full Label30 mL NDC: 75518-111-02 One Up Hand Sanitizer 30ml Full LabelOne Up Hand Sanitizer 30ml Full Label50 mL NDC: 75518-111-03 One Up Hand Sanitizer 50ml Full LabelOne Up Hand Sanitizer 50ml Full Label60 mL NDC: 75518-111-04 One Up Hand Sanitizer 60ml Full LabelOne Up Hand Sanitizer 60ml Full Label100 mL NDC: 75518-111-05 One Up Hand Sanitizer 100ml Full LabelOne Up Hand Sanitizer 100ml Full Label120 mL NDC: 75518-111-06 One Up Hand Sanitizer 120ml Full LabelOne Up Hand Sanitizer 120ml Full Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN2
1039339ethanol 0.8 ML/ML Topical SolutionSCD2
1039339ethanol 80 % Topical SolutionSY2

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
75518-111-012021-07-23C16284748780-1c7ccaba7-1320-fd44-e053-dadaa90aa01bHand Sanitizer
75518-111-022021-07-23C16284748780-1c7ccaba7-1320-fd44-e053-dadaa90aa01bHand Sanitizer
75518-111-032021-07-23C16284748780-1c7ccaba7-1320-fd44-e053-dadaa90aa01bHand Sanitizer
75518-111-042021-07-23C16284748780-1c7ccaba7-1320-fd44-e053-dadaa90aa01bHand Sanitizer
75518-111-052021-07-23C16284748780-1c7ccaba7-1320-fd44-e053-dadaa90aa01bHand Sanitizer
75518-111-062021-07-23C16284748780-1c7ccaba7-1320-fd44-e053-dadaa90aa01bHand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75518-111-01Hand Sanitizer15 mL in 1 BOTTLESOLUTION152
75518-111-02Hand Sanitizer30 mL in 1 BOTTLESOLUTION302
75518-111-03Hand Sanitizer50 mL in 1 BOTTLESOLUTION502
75518-111-04Hand Sanitizer60 mL in 1 BOTTLESOLUTION602
75518-111-05Hand Sanitizer100 mL in 1 BOTTLESOLUTION1002
75518-111-06Hand Sanitizer120 mL in 1 BOTTLESOLUTION1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75518-111HAND SANITIZER (ALCOHOL) SOLUTION [ONE UP MANUFACTURING LLC]2Legacy NDC, 6 package rows20200421_a3c363de-b318-668b-e053-2995a90ad6ed.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
75518-11175518-111-01, 75518-111-02, 75518-111-04, 75518-111-03, 75518-111-05, 75518-111-06

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
ALCOHOL3K9958V90MACTIB

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
a3c35faa-606a-152f-e053-2a95a90abfe8a3c363de-b318-668b-e053-2995a90ad6ed2020-04-20WarningsExact identifier
spl id: a3c35faa-606a-152f-e053-2a95a90abfe8
spl set id: a3c363de-b318-668b-e053-2995a90ad6ed

Reported adverse events (FAERS/openFDA)#

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