FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
TJP Labs Inc
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:53:03

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% 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.

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

water, aloe barbadensis extract, glycerin, triisopropanolamine, carbomer, d-alpha tocopheryl acetate, propylene glycol, fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

120 ml

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
581662ethanol 70 % Topical GelPSN7
581662ethanol 0.7 ML/ML Topical GelSCD7
581662ethanol 70 % Topical GelSY7
581662ethyl alcohol 70 % Topical GelSY7

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77478-455-012024-07-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-052024-07-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-102024-07-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-112024-07-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-122024-07-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-252024-07-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-372024-07-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-502024-07-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-012024-01-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-052024-01-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-102024-01-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-112024-01-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-122024-01-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-252024-01-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-372024-01-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm
77478-455-502024-01-30C16284748780-11030e365-383c-111a-e063-dadaa90a10e2Canpalm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77478-455-01Hand Sanitizer1000 mL in 1 BOTTLEGEL10007
77478-455-05Hand Sanitizer500 mL in 1 BOTTLEGEL5007
77478-455-10Hand Sanitizer100 mL in 1 BOTTLEGEL1007
77478-455-11Hand Sanitizer1000000 mL in 1 CONTAINERGEL10000007
77478-455-12Hand Sanitizer120 mL in 1 BOTTLEGEL1207
77478-455-25Hand Sanitizer250 mL in 1 BOTTLEGEL2507
77478-455-37Hand Sanitizer3785 mL in 1 BOTTLEGEL37857
77478-455-50Hand Sanitizer50 mL in 1 BOTTLEGEL507

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77478-455HAND SANITIZER (ALCOHOL) GEL [TJP LABS INC]7Legacy NDC, 8 package rows20230111_a512d924-3c1e-113b-e053-2995a90aa475.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
77478-45577478-455-12, 77478-455-50, 77478-455-10, 77478-455-25, 77478-455-01, 77478-455-05, 77478-455-37, 77478-455-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TRIISOPROPANOLAMINEW9EN9DLM98IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

Source Document#

Source XML · Source PDF

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
f1ed895e-4636-e678-e053-2995a90aa08ba512d924-3c1e-113b-e053-2995a90aa4752023-01-10WarningsExact identifier
spl id: f1ed895e-4636-e678-e053-2995a90aa08b
spl set id: a512d924-3c1e-113b-e053-2995a90aa475

Reported adverse events (FAERS/openFDA)#

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