FDA.reportPublic FDA data

DISPOSABLE HAND SANITIZER

Manufacturer
JINHUA RONGGUO TECHNOLOGY CO., LTD
Effective date
2020-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:14

Label at a glance#

ProductDISPOSABLE HAND SANITIZER
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Wet hands thoroughly with product and rub until dry without wiping For children under 6, use only under adult supervision Not recommended for infants

Storage and handling

Do not store above 105F May discolor some fabrics Harmful to wood finishes and plastics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 75% 

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

To decrease bacteria on the skin that could cause disease

Recommended for repeated use

Use anywhere without water

Warnings

WARNINGS SECTION

For external use only -hands

Flammable. Keep away from heat and flame

OTC - WHEN USING SECTION

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Avoid contact with broken skin

Do not inhale or ingest

OTC - STOP USE SECTION

Discontinue if skin becomes irritated and ask a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingest, seek professional assistance or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hands thoroughly with product and rub until dry without wiping
  • For children under 6, use only under adult supervision
  • Not recommended for infants

Other information

STORAGE AND HANDLING SECTION

Do not store above 105F

May discolor some fabrics

Harmful to wood finishes and plastics

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, glycerin, carbomer, aminomethyl propanol, triethanolamine, fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN1
1305100ethanol 0.75 ML/ML Topical GelSCD1
1305100ethanol 75 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78165-001-012022-01-28C16284748780-1d6a99b39-3e5d-a426-e053-dadaa90af4c2ed090dda-eb82-44e7-8438-7d124fcbd212
78165-001-022022-01-28C16284748780-1d6a99b39-3e5d-a426-e053-dadaa90af4c2ed090dda-eb82-44e7-8438-7d124fcbd212
78165-001-032022-01-28C16284748780-1d6a99b39-3e5d-a426-e053-dadaa90af4c2ed090dda-eb82-44e7-8438-7d124fcbd212
78165-001-042022-01-28C16284748780-1d6a99b39-3e5d-a426-e053-dadaa90af4c2ed090dda-eb82-44e7-8438-7d124fcbd212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78165-001-01DISPOSABLE HAND SANITIZER30 mL in 1 BOTTLEGEL301
78165-001-02DISPOSABLE HAND SANITIZER60 mL in 1 BOTTLEGEL601
78165-001-03DISPOSABLE HAND SANITIZER250 mL in 1 BOTTLEGEL2501
78165-001-04DISPOSABLE HAND SANITIZER500 mL in 1 BOTTLEGEL5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78165-001DISPOSABLE HAND SANITIZER (ALCOHOL) GEL [JINHUA RONGGUO TECHNOLOGY CO., LTD]1Legacy NDC, 4 package rows20200529_ed090dda-eb82-44e7-8438-7d124fcbd212.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
78165-00178165-001-01, 78165-001-02, 78165-001-03, 78165-001-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CARBOMER 934Z135WT9208IACT
TROLAMINE9O3K93S3TKIACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
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
a6bc5d5c-da6a-abdf-e053-2995a90a6c80ed090dda-eb82-44e7-8438-7d124fcbd2122020-05-28WarningsExact identifier
spl id: a6bc5d5c-da6a-abdf-e053-2995a90a6c80
spl set id: ed090dda-eb82-44e7-8438-7d124fcbd212

Reported adverse events (FAERS/openFDA)#

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