FDA.reportPublic FDA data

Instant Hand Sanitizer

Manufacturer
ZHEJIANG SHUNAN INDUSTRY&TRADE CO.,LTD | ZHEJIANG SHUNAN INDUSTRY & TRADE CO., LTD
Effective date
2020-08-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:24:59

Label at a glance#

ProductInstant Hand Sanitizer
Active ingredientALCOHOL
Label structure13 sections

Dosage and administration

wet hands thoroughly with product and allow to dry without wiping.

Storage and handling

Store below 105℉

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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% 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

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

to decrease bacteria on the skin, only when water is not available.

Warnings

WARNINGS SECTION

  • Flammable. Keep away from fire and flame.
  • For external use only.

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 . Do not get into eyes. If contact occurs, rinse eyes thoroughly with water. May discolor some fabrics.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • Irritation or redness develop
  • Keep out of reach of children
  • If swallowed. get medical help or contact a Poison Control Center right away.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands thoroughly with product and allow to dry without wiping.

Other information

STORAGE AND HANDLING SECTION

  • Store below 105℉

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water,Carbomer, Triethanolamine, Glycerol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

59.1 mL in 1 Bottle NDC: 75556-591-01

59.1 ml label59.1 ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1305100ethanol 75 % Topical GelPSN2
1305100ethanol 0.75 ML/ML Topical GelSCD2
1305100ethanol 75 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75556-591-012022-01-28C16284748780-1d6a99b39-7926-a426-e053-dadaa90af4c275556-591 59.1 ml SHUNAN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75556-591-01Instant Hand Sanitizer59.1 mL in 1 BOTTLEGEL59.12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75556-591INSTANT HAND SANITIZER (ALCOHOL) GEL [ZHEJIANG SHUNAN INDUSTRY&TRADE CO.,LTD]2Legacy NDC, 1 package rows20200818_ad0a9904-2676-98fd-e053-2a95a90a6d70.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75556-59175556-591-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
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
ad13915b-d6bc-6caf-e053-2a95a90a688cad0a9904-2676-98fd-e053-2a95a90a6d702020-08-17WarningsExact identifier
spl id: ad13915b-d6bc-6caf-e053-2a95a90a688c
spl set id: ad0a9904-2676-98fd-e053-2a95a90a6d70

Reported adverse events (FAERS/openFDA)#

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