FDA.reportPublic FDA data

Instant Hand Sanitizer

Manufacturer
Jinhua Jinpan Development Zone Shangmei Cosmetics Co.,Ltd
Effective date
2020-06-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:16:06

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
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#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerine (2.00% v/v).
  3. Aminomethyl Propanediol (0.5% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% 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.
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 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

Ethyl Alcohol Aqua Modified acryilc polymer Glycerine Aminomethyl propanol Fragrance

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 ml NDC: 78059-001-01 50 mL Label50 mL Label

60 ml NDC: 78059-001-02 60 mL Label60 mL Label

100 ml NDC: 78059-001-03 100 mL Label100 mL Label

150 ml NDC: 78059-001-04 150 mL Label150 mL Label

250 ml NDC: 78059-001-05 250 mL Label250 mL Label300 ml NDC: 78059-001-06 300 mL Label300 mL Label500 ml NDC: 78059-001-07 500 mL Label500 mL Label1000 ml NDC: 78059-001-08 1000 mL Label1000 mL Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78059-001-012021-07-23C16284748780-1c7ccaba7-1b87-fd44-e053-dadaa90aa01ba670e1d0-158e-a19e-e053-2995a90a8718
78059-001-022021-07-23C16284748780-1c7ccaba7-1b87-fd44-e053-dadaa90aa01ba670e1d0-158e-a19e-e053-2995a90a8718
78059-001-032021-07-23C16284748780-1c7ccaba7-1b87-fd44-e053-dadaa90aa01ba670e1d0-158e-a19e-e053-2995a90a8718
78059-001-042021-07-23C16284748780-1c7ccaba7-1b87-fd44-e053-dadaa90aa01ba670e1d0-158e-a19e-e053-2995a90a8718
78059-001-052021-07-23C16284748780-1c7ccaba7-1b87-fd44-e053-dadaa90aa01ba670e1d0-158e-a19e-e053-2995a90a8718
78059-001-062021-07-23C16284748780-1c7ccaba7-1b87-fd44-e053-dadaa90aa01ba670e1d0-158e-a19e-e053-2995a90a8718
78059-001-072021-07-23C16284748780-1c7ccaba7-1b87-fd44-e053-dadaa90aa01ba670e1d0-158e-a19e-e053-2995a90a8718
78059-001-082021-07-23C16284748780-1c7ccaba7-1b87-fd44-e053-dadaa90aa01ba670e1d0-158e-a19e-e053-2995a90a8718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78059-001-01Instant Hand Sanitizer50 mL in 1 BOTTLEGEL502
78059-001-02Instant Hand Sanitizer60 mL in 1 BOTTLEGEL602
78059-001-03Instant Hand Sanitizer100 mL in 1 BOTTLEGEL1002
78059-001-04Instant Hand Sanitizer150 mL in 1 BOTTLEGEL1502
78059-001-05Instant Hand Sanitizer250 mL in 1 BOTTLEGEL2502
78059-001-06Instant Hand Sanitizer300 mL in 1 BOTTLEGEL3002
78059-001-07Instant Hand Sanitizer500 mL in 1 BOTTLEGEL5002
78059-001-08Instant Hand Sanitizer1000 mL in 1 BOTTLEGEL10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78059-001INSTANT HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [JINHUA JINPAN DEVELOPMENT ZONE SHANGMEI COSMETICS CO.,LTD]2Legacy NDC, 8 package rows20200605_a670e1d0-158e-a19e-e053-2995a90a8718.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
78059-00178059-001-01, 78059-001-02, 78059-001-03, 78059-001-04, 78059-001-05, 78059-001-06, 78059-001-07, 78059-001-08

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
a73885a7-17a4-22e5-e053-2a95a90a4b22a670e1d0-158e-a19e-e053-2995a90a87182020-06-03WarningsExact identifier
spl id: a73885a7-17a4-22e5-e053-2a95a90a4b22
spl set id: a670e1d0-158e-a19e-e053-2995a90a8718

Reported adverse events (FAERS/openFDA)#

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