FDA.reportPublic FDA data

75% Alcohol Disposable Disinfectant Gel

Manufacturer
Guangzhou Pinshang Biotechnology Development Co.,Ltd.
Effective date
2020-05-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:10:20

Label at a glance#

Product75% Alcohol Disposable Disinfectant Gel
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#

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. 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

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

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100ml NDC:75614-111-01 100ml label100ml label

60ml NDC:75614-111-02 60ml60ml

236ml NDC:75614-111-03 236ml label236ml label

250ml NDC:75614-111-04 250ml250ml

300ml NDC:75614-111-05 300ml300ml

500ml NDC:75614-111-06 500ml label500ml label

30ml NDC:75614-111-07 30ml label30ml label

200ml NDC:75614-111-08 200ml label200ml label

1000ml/1L NDC:75614-111-09 1000ml label1000ml label

3800ml/3.8L NDC:75614-111-10 3.8L label3.8L label

5000ml/5L NDC:75614-111-11 5L label5L 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75614-111-012022-01-28C16284748780-1d6a99b39-570f-a426-e053-dadaa90af4c2hand sanitizer-pinshang
75614-111-022022-01-28C16284748780-1d6a99b39-570f-a426-e053-dadaa90af4c2hand sanitizer-pinshang
75614-111-032022-01-28C16284748780-1d6a99b39-570f-a426-e053-dadaa90af4c2hand sanitizer-pinshang
75614-111-042022-01-28C16284748780-1d6a99b39-570f-a426-e053-dadaa90af4c2hand sanitizer-pinshang
75614-111-052022-01-28C16284748780-1d6a99b39-570f-a426-e053-dadaa90af4c2hand sanitizer-pinshang
75614-111-062022-01-28C16284748780-1d6a99b39-570f-a426-e053-dadaa90af4c2hand sanitizer-pinshang
75614-111-072022-01-28C16284748780-1d6a99b39-570f-a426-e053-dadaa90af4c2hand sanitizer-pinshang
75614-111-082022-01-28C16284748780-1d6a99b39-570f-a426-e053-dadaa90af4c2hand sanitizer-pinshang
75614-111-092022-01-28C16284748780-1d6a99b39-570f-a426-e053-dadaa90af4c2hand sanitizer-pinshang
75614-111-102022-01-28C16284748780-1d6a99b39-570f-a426-e053-dadaa90af4c2hand sanitizer-pinshang
75614-111-112022-01-28C16284748780-1d6a99b39-570f-a426-e053-dadaa90af4c2hand sanitizer-pinshang

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75614-111-0175% Alcohol Disposable Disinfectant Gel100 mL in 1 BOTTLE, DROPPERGEL1002
75614-111-0275% Alcohol Disposable Disinfectant Gel60 mL in 1 BOTTLE, DROPPERGEL602
75614-111-0375% Alcohol Disposable Disinfectant Gel236 mL in 1 BOTTLE, DROPPERGEL2362
75614-111-0475% Alcohol Disposable Disinfectant Gel250 mL in 1 BOTTLE, DROPPERGEL2502
75614-111-0575% Alcohol Disposable Disinfectant Gel300 mL in 1 BOTTLE, DROPPERGEL3002
75614-111-0675% Alcohol Disposable Disinfectant Gel500 mL in 1 BOTTLE, DROPPERGEL5002
75614-111-0775% Alcohol Disposable Disinfectant Gel30 mL in 1 BOTTLE, DROPPERGEL302
75614-111-0875% Alcohol Disposable Disinfectant Gel200 mL in 1 BOTTLE, DROPPERGEL2002
75614-111-0975% Alcohol Disposable Disinfectant Gel1000 mL in 1 BOTTLE, DROPPERGEL10002
75614-111-1075% Alcohol Disposable Disinfectant Gel3800 mL in 1 BOTTLE, DROPPERGEL38002
75614-111-1175% Alcohol Disposable Disinfectant Gel5000 mL in 1 BOTTLE, DROPPERGEL50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75614-11175% ALCOHOL DISPOSABLE DISINFECTANT GEL (ALCOHOL) GEL [GUANGZHOU PINSHANG BIOTECHNOLOGY DEVELOPMENT CO.,LTD.]2Legacy NDC, 11 package rows20200509_a46e179a-116a-cad7-e053-2a95a90a9a68.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
75614-11175614-111-01, 75614-111-02, 75614-111-03, 75614-111-04, 75614-111-05, 75614-111-06, 75614-111-07, 75614-111-08, 75614-111-09, 75614-111-10, 75614-111-11

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
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

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
a51b1ebb-3290-f9d0-e053-2995a90aa4a1a46e179a-116a-cad7-e053-2a95a90a9a682020-05-07WarningsExact identifier
spl id: a51b1ebb-3290-f9d0-e053-2995a90aa4a1
spl set id: a46e179a-116a-cad7-e053-2a95a90a9a68

Reported adverse events (FAERS/openFDA)#

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