FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Bluebonnet Petrochemical Solutions
Effective date
2020-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:06:28

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

HAND SANITIZER, ALCOHOL ANTISEPTIC 80%, ANTISEPTIC HAND RUB NON-STERILE SOLUTION,ecowerks.com, bps-us.com, 1 Gallon (3785 mL)

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

HAND SANITIZER - ALCOHOL ANTISEPTIC 80%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANTISEPTIC HAND RUB NON-STERILE SOLUTION

3785 mL NDC: 75339-801-01

label imagelabel image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039339ethanol 80 % Topical SolutionPSN1
1039339ethanol 0.8 ML/ML Topical SolutionSCD1
1039339ethanol 80 % 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
75339-801-012022-01-28C16284748780-1d6a99b39-bd51-a426-e053-dadaa90af4c2a34cd039-588f-296e-e053-2a95a90a66f7
75339-801-022022-01-28C16284748780-1d6a99b39-bd51-a426-e053-dadaa90af4c2a34cd039-588f-296e-e053-2a95a90a66f7
75339-801-032022-01-28C16284748780-1d6a99b39-bd51-a426-e053-dadaa90af4c2a34cd039-588f-296e-e053-2a95a90a66f7
75339-801-042022-01-28C16284748780-1d6a99b39-bd51-a426-e053-dadaa90af4c2a34cd039-588f-296e-e053-2a95a90a66f7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75339-801-01Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICSOLUTION37851
75339-801-02Hand Sanitizer1597 mL in 1 BOTTLE, PLASTICSOLUTION15971
75339-801-03Hand Sanitizer473 mL in 1 BOTTLE, PLASTICSOLUTION4731
75339-801-04Hand Sanitizer236.6 mL in 1 BOTTLE, PLASTICSOLUTION236.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75339-801HAND SANITIZER (ALCOHOL) SOLUTION [BLUEBONNET PETROCHEMICAL SOLUTIONS]1Legacy NDC, 4 package rows20200416_a34cd039-588f-296e-e053-2a95a90a66f7.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
75339-80175339-801-01, 75339-801-02, 75339-801-04, 75339-801-03

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
a34ccf1e-69ca-4fd3-e053-2a95a90a473ea34cd039-588f-296e-e053-2a95a90a66f72020-04-14WarningsExact identifier
spl id: a34ccf1e-69ca-4fd3-e053-2a95a90a473e
spl set id: a34cd039-588f-296e-e053-2a95a90a66f7

Reported adverse events (FAERS/openFDA)#

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