Hand Sanitizer

Manufacturer
RMS International (USA) Inc. | Jiangxi Iris Chemical Co.,ltd
Effective date
2020-07-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:20:37

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure13 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#

DIY Hand Sanitizer Set

SPL UNCLASSIFIED SECTION

This is a hand sanitizer is manufactured in accordance with the applicable topical anti-microbial OTC Monograph (Not Final).

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 74% 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

WARNING: Flammable. Keep away from fire or flame. For external use only. Do not use it near eye area. In case of contact, rinse eyes thouroughly with water. Stop use and ask doctor if irritation or rash appears and lasts. Keep out of the reach of children.

Do not use

OTC - DO NOT USE SECTION

On 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, Carbomer, triethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2369351ethanol 74 % Topical SolutionPSN3
2369351ethanol 0.74 ML/ML Topical SolutionSCD3
2369351ethanol 74 % Topical SolutionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77839-123-452022-01-28C16284748780-1d6a99b39-5c23-a426-e053-dadaa90af4c2a58b3821-3b67-0add-e053-2995a90a0e06

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77839-123-45Hand Sanitizer30 mL in 1 BOXLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77839-123HAND SANITIZER (ALCOHOL) LIQUID [RMS INTERNATIONAL (USA) INC.]3Legacy NDC, 1 package rows20200709_a58b3821-3b67-0add-e053-2995a90a0e06.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
77839-12377839-123-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
a9f39618-44bf-4b7c-e053-2995a90a55dea58b3821-3b67-0add-e053-2995a90a0e062020-07-08WarningsExact identifier
spl id: a9f39618-44bf-4b7c-e053-2995a90a55de
spl set id: a58b3821-3b67-0add-e053-2995a90a0e06

Reported adverse events (FAERS/openFDA)#

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