FDA.reportPublic FDA data

SaniHealth Labs Hand Sanitizer

Manufacturer
Sanihealth Labs Inc.
Effective date
2020-08-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:25:33

Label at a glance#

ProductSaniHealth Labs Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

helps reduce bacteria on the skin that could cause disease

Dosage and administration

Place enough product in your palm to thoroughly cover your hands Rub hands together briskly until dry Children should be supervised when using this product. For personal and occasional domestic use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70%v/v.

Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Safety Instructions

OTHER SAFETY INFORMATION

Flammable, Keep away from fire and flame

Ask Doctor

OTC - ASK DOCTOR SECTION

Stop Use and Ask a doctor if irritation or redness develops

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control right away

Other Information

OTHER SAFETY INFORMATION

Store below 15-30°C

May discolor certain fabrics or surfaces.

Avoid freezing and excessive heat

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, hydrolyzed jojoba esters, glycerin, carbopol, fragrance, aminomethyl propanol, denatonium benozate

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product in your palm to thoroughly cover your hands
  • Rub hands together briskly until dry
  • Children should be supervised when using this product.
  • For personal and occasional domestic use

Warnings

WARNINGS SECTION

For external use only.

Flammable. Keep away from fire or flame.

Uses

INDICATIONS & USAGE SECTION

  • helps reduce bacteria on the skin that could cause disease

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

22

33

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN2
581662ethanol 0.7 ML/ML Topical GelSCD2
581662ethanol 70 % Topical GelSY2
581662ethyl alcohol 70 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79861-000-042022-01-28C16284748780-1d6a99b39-9442-a426-e053-dadaa90af4c2SaniHealth Labs Hand Sanitizer
79861-000-262022-01-28C16284748780-1d6a99b39-9442-a426-e053-dadaa90af4c2SaniHealth Labs Hand Sanitizer
79861-000-532022-01-28C16284748780-1d6a99b39-9442-a426-e053-dadaa90af4c2SaniHealth Labs Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79861-000-04SaniHealth Labs Hand Sanitizer4000 mL in 1 BOTTLEGEL40002
79861-000-26SaniHealth Labs Hand Sanitizer266 mL in 1 BOTTLEGEL2662
79861-000-53SaniHealth Labs Hand Sanitizer532 mL in 1 BOTTLEGEL5322

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79861-000SANIHEALTH LABS HAND SANITIZER (ETHYL ALCOHOL) GEL [SANIHEALTH LABS INC.]2Legacy NDC, 3 package rows20200823_ad7899a7-747f-4114-e053-2995a90ae356.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79861-00079861-000-26, 79861-000-04, 79861-000-53

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
DENATONIUM BENZOATE4YK5Z54AT2IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
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
ad78d38b-20bd-3f9d-e053-2995a90a0776ad7899a7-747f-4114-e053-2995a90ae3562020-08-22WarningsExact identifier
spl id: ad78d38b-20bd-3f9d-e053-2995a90a0776
spl set id: ad7899a7-747f-4114-e053-2995a90ae356

Reported adverse events (FAERS/openFDA)#

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