FDA.reportPublic FDA data

Sanityzer for All

Manufacturer
JB Limited
Effective date
2020-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:26:32

Label at a glance#

ProductSanityzer for All
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

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

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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethyl alcohol 70%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

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

When using this product

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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTHER SAFETY INFORMATION

-Store between 15-30C (59-86F).

-Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water USP, glycerin, Maxxxgel ez1, Ceraphyl, fragrance

Sanityzer for All

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabellabellabellabellabellabellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN1
581662ethanol 0.7 ML/ML Topical GelSCD1
581662ethanol 70 % Topical GelSY1
581662ethyl alcohol 70 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78194-000-002022-01-28C16284748780-1d6a99b39-4631-a426-e053-dadaa90af4c2Sanityzer for All
78194-000-012022-01-28C16284748780-1d6a99b39-4631-a426-e053-dadaa90af4c2Sanityzer for All
78194-000-022022-01-28C16284748780-1d6a99b39-4631-a426-e053-dadaa90af4c2Sanityzer for All
78194-000-032022-01-28C16284748780-1d6a99b39-4631-a426-e053-dadaa90af4c2Sanityzer for All
78194-000-042022-01-28C16284748780-1d6a99b39-4631-a426-e053-dadaa90af4c2Sanityzer for All

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78194-000-00Sanityzer for All3785 mL in 1 BOTTLEGEL37851
78194-000-01Sanityzer for All251 mL in 1 BOTTLEGEL2511
78194-000-02Sanityzer for All500 mL in 1 BOTTLEGEL5001
78194-000-03Sanityzer for All946 mL in 1 BOTTLEGEL9461
78194-000-04Sanityzer for All60 mL in 1 BOTTLEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78194-000SANITYZER FOR ALL (ETHYL ALCOHOL 70%) GEL [JB LIMITED]1Legacy NDC, 5 package rows20200902_acaf5c27-978d-6bfb-e053-2a95a90a1254.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
78194-00078194-000-00, 78194-000-01, 78194-000-02, 78194-000-03, 78194-000-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURYL LACTATEG5SU0BFK7OIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
RAPIDGEL EZ133JH4A7R2KIACT

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
acaf2cd6-f2f3-64a4-e053-2995a90abd31acaf5c27-978d-6bfb-e053-2a95a90a12542020-08-12WarningsExact identifier
spl id: acaf2cd6-f2f3-64a4-e053-2995a90abd31
spl set id: acaf5c27-978d-6bfb-e053-2a95a90a1254

Reported adverse events (FAERS/openFDA)#

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