Hand Sanitizer

Manufacturer
Specoil, Llc
Effective date
2020-05-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:13

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure9 sections

Storage and handling

Other information:  Store between 15-30  0 C (59-86  0 F). Avoid freezing and excessive heat above 40  0 C (104  0 F).

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

Uses: Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

WARNINGS SECTION

Warnings: For external use only. Flammable. Keep away from heat or flame. Do not use on children less than 2 months of age

or open skin wounds.

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 skin 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.

DOSAGE & ADMINISTRATION SECTION

Directions: 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 SECTION

Other information: Store between 15-30 0C (59-86 0F).
Avoid freezing and excessive heat above 40 0C (104 0F).

INACTIVE INGREDIENT SECTION

Inactive ingredients: glycerin, hydrogen peroxide, purified water

SPL UNCLASSIFIED SECTION

Non‐sterile Solution

SpecOil LLC

333 N Sam Houston Pkwy E STE 550

Houston, TX 77060‐2438

832.399.7950

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78282-001-012022-01-28C16284748780-1d6a99b39-8ce3-a426-e053-dadaa90af4c2Specoil Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78282-001-01Hand Sanitizer60 mL in 1 BOTTLE, PLASTICSOLUTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78282-001HAND SANITIZER (ALCOHOL) SOLUTION [SPECOIL, LLC]1Legacy NDC, 1 package rows20200529_c2fdb1c6-30ab-437d-812f-fb1755622bd8.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
78282-00178282-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
b90522c0-dda9-4767-8732-ddedba53a6dec2fdb1c6-30ab-437d-812f-fb1755622bd82020-05-22WarningsExact identifier
spl id: b90522c0-dda9-4767-8732-ddedba53a6de
spl set id: c2fdb1c6-30ab-437d-812f-fb1755622bd8

Reported adverse events (FAERS/openFDA)#

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