FDA.reportPublic FDA data

SanaSkin Hand and Body Sanitizer

Manufacturer
Sanitin Products, LLC
Effective date
2020-07-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:17

Label at a glance#

ProductSanaSkin Hand and Body Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

Uses: As a topical sanitizer. To help reduce the risk and spread of infection as well as communicable diseases by killing germs that reside on the surface of the skin.

Dosage and administration

Directions: Apply directly to hands and rub thoroughly over desired areas. Continue rubbing until dry. Use frequently to avoid spreading germs.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:

Benzalkonium chloride 0.11 - 0.13%

Purpose

(sanitizing agent)

Purpose

OTC - PURPOSE SECTION

Purpose:

Sanitizing agent

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

Apply directly to hands and rub thoroughly over desired areas. Continue rubbing until dry. Use frequently to avoid spreading germs.

Uses

INDICATIONS & USAGE SECTION

Uses:

As a topical sanitizer. To help reduce the risk and spread of infection as well as communicable diseases by killing germs that reside on the surface of the skin.

Warning

WARNINGS SECTION

Warning:

For external use only. do not use in eyes. In case of eye contact, immediately flush with water and seek medical advise. If swallowed, get medical help or contact poison control center right away. Discontinue use if skin irritation or redness develops. Not for use on sensitive areas of the body or burns. Keep out of reach of children

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water 99.83%, carbamide 0.04%

SanaSkin 275 gallon label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanaSkin 275 gallon tote labelSanaSkin 275 gallon tote label

SanaSkin 55 gallon Drum Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanaSkin 55 gallon drumSanaSkin 55 gallon drum

SanaSkin 1 Gallon Jug

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanaSkin 1 Gallon JugSanaSkin 1 Gallon Jug

SanaSkin 32oz bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanaSkin 1 LiterSanaSkin 1 Liter

SanaSkin 8oz Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanaSkin 240 mLSanaSkin 240 mL

SanaSkin 4oz bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanaSkin 120 mL BottleSanaSkin 120 mL Bottle

SanaSkin 1.7 oz bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanaSkin 50 mL bottleSanaSkin 50 mL bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN1
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD1
1020365benzalkonium chloride 0.13 % Topical FoamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79637-120-012022-01-28C16284748780-1d6a99b39-5d25-a426-e053-dadaa90af4c2SanaSkin Sanitizer Hand Sanitizer
79637-120-022022-01-28C16284748780-1d6a99b39-5d25-a426-e053-dadaa90af4c2SanaSkin Sanitizer Hand Sanitizer
79637-120-032022-01-28C16284748780-1d6a99b39-5d25-a426-e053-dadaa90af4c2SanaSkin Sanitizer Hand Sanitizer
79637-120-042022-01-28C16284748780-1d6a99b39-5d25-a426-e053-dadaa90af4c2SanaSkin Sanitizer Hand Sanitizer
79637-120-082022-01-28C16284748780-1d6a99b39-5d25-a426-e053-dadaa90af4c2SanaSkin Sanitizer Hand Sanitizer
79637-120-402022-01-28C16284748780-1d6a99b39-5d25-a426-e053-dadaa90af4c2SanaSkin Sanitizer Hand Sanitizer
79637-120-412022-01-28C16284748780-1d6a99b39-5d25-a426-e053-dadaa90af4c2SanaSkin Sanitizer Hand Sanitizer
79637-120-502022-01-28C16284748780-1d6a99b39-5d25-a426-e053-dadaa90af4c2SanaSkin Sanitizer Hand Sanitizer
79637-120-702022-01-28C16284748780-1d6a99b39-5d25-a426-e053-dadaa90af4c2SanaSkin Sanitizer Hand Sanitizer
79637-120-802022-01-28C16284748780-1d6a99b39-5d25-a426-e053-dadaa90af4c2SanaSkin Sanitizer Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79637-120-01SanaSkin Hand and Body Sanitizer50 mL in 1 BOTTLE, PUMPSOLUTION501
79637-120-02SanaSkin Hand and Body Sanitizer100 mL in 1 BOTTLE, PUMPSOLUTION1001
79637-120-03SanaSkin Hand and Body Sanitizer20 mL in 1 BOTTLE, SPRAYSOLUTION201
79637-120-04SanaSkin Hand and Body Sanitizer120 mL in 1 BOTTLE, SPRAYSOLUTION1201
79637-120-08SanaSkin Hand and Body Sanitizer240 mL in 1 BOTTLE, SPRAYSOLUTION2401
79637-120-40SanaSkin Hand and Body Sanitizer1000 mL in 1 BOTTLE, PLASTICSOLUTION10001
79637-120-41SanaSkin Hand and Body Sanitizer1000 mL in 1 BOTTLE, SPRAYSOLUTION10001
79637-120-50SanaSkin Hand and Body Sanitizer3740 mL in 1 JUGSOLUTION37401
79637-120-70SanaSkin Hand and Body Sanitizer208000 mL in 1 DRUMSOLUTION2080001
79637-120-80SanaSkin Hand and Body Sanitizer1054000 mL in 1 CONTAINERSOLUTION10540001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79637-120SANASKIN HAND AND BODY SANITIZER SOLUTION [SANITIN PRODUCTS, LLC]1Legacy NDC, 10 package rows20200723_aaf5e4dd-a284-0a74-e053-2a95a90ab387.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
79637-12079637-120-80, 79637-120-70, 79637-120-50, 79637-120-40, 79637-120-41, 79637-120-08, 79637-120-04, 79637-120-01, 79637-120-02, 79637-120-03
78003-120

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
UREA8W8T17847WIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT

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
aaf5e4dd-a285-0a74-e053-2a95a90ab387aaf5e4dd-a284-0a74-e053-2a95a90ab3872020-07-21WarningsExact identifier
spl id: aaf5e4dd-a285-0a74-e053-2a95a90ab387
spl set id: aaf5e4dd-a284-0a74-e053-2a95a90ab387

Reported adverse events (FAERS/openFDA)#

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