FDA.reportPublic FDA data

Hand Sanitizer Original

Manufacturer
Ningbo Rejoice International | China Ningbo Shangge Technology Co., Ltd.
Effective date
2025-02-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:55:17

Label at a glance#

ProductHand Sanitizer Original 8oz
Active ingredientALCOHOL
Label structure12 sections

Dosage and administration

Wet hands thoroughly with product briskly rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store at room temperature may discolor certain fabrics

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 70% v/v.

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

  • for handwashing to decrease bacteria on the skin
  • recommended for repeated use

Warnings

WARNINGS SECTION

For external use only. Flammable, keep away from heat or flame

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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rednees develp and persist for more than 72 hours.

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

  • Wet hands thoroughly with product
  • briskly 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 at room temperature
  • may discolor certain fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate.

OTC - QUESTIONS SECTION

1-855-345-5575

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN2
582753ethanol 0.7 ML/ML Topical SolutionSCD2
582753ethanol 70 % Topical SolutionSY2
582753ethyl alcohol 70 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-124-012025-02-13C16284748780-12cef2736-7ac1-d83d-e063-dadaa90ab31fb08ec92b-e63e-2dab-e053-2995a90a0948
57337-124-012025-01-30C16284748780-12cef2736-7ac1-d83d-e063-dadaa90ab31fb08ec92b-e63e-2dab-e053-2995a90a0948

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-124-01Hand Sanitizer Original8oz236 mL in 1 BOTTLELIQUID2362

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-124HAND SANITIZER ORIGINAL 8OZ (ALCOHOL) LIQUID [NINGBO REJOICE INTERNATIONAL]2Current NDC, Legacy NDC, 1 package rows20250215_b08ec92b-e63e-2dab-e053-2995a90a0948.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
57337-12457337-124-01

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
TROLAMINE9O3K93S3TKIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
ALOEV5VD430YW9IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
Hand Sanitizer Original 8ozALCOHOLNingbo Rejoice Internationalb08ec92b-e63e-2dab-e053-2995a90a09482025-02-13WarningsExact identifier
ndc (package): 57337-124-01
ndc (product): 57337-124
ndc11 (package): 57337012401
spl id: 2e0197fd-4e32-93b9-e063-6394a90a285a
spl set id: b08ec92b-e63e-2dab-e053-2995a90a0948

Reported adverse events (FAERS/openFDA)#

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