FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
TRANG LY PHARMA TRADE COMPANY LIMITED
Effective date
2020-10-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:31:38

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure14 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 in dry and cool place

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 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Use

INDICATIONS & USAGE SECTION

Dry Hand Sanitizer helps prevent the development of bacteria on the skin.

It moisturizes and softens the hand skin with the sweet fragrance.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • for children under 36 months.

OTC - WHEN USING SECTION


Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.


For children: need to be supervised by adults when using it.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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 in dry and cool place

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

RECENT MAJOR CHANGES SECTION

Update Uses: from template to label description.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep our of reach of children

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 mL NDC: 90098-100-01

90098-100-0190098-100-01

250 mL NDC: 90098-100-02

90098-100-0290098-100-02

500 mL NDC: 90098-100-03

90098-100-0390098-100-03

1000 mL NDC: 90098-100-04

90098-100-0490098-100-04

2000 mL NDC: 90098-100-05

90098-100-0590098-100-05

10000 mL NDC: 90098-100-06

90098-100-0690098-100-06

20000 mL NDC: 90098-100-07

90098-100-0790098-100-07

59 mL NDC: 90098-100-08

90098-100-0890098-100-08

1 Gallon NDC: 90098-100-09

90098-100-0990098-100-09

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2277550ethanol 72 % Topical GelPSN4
2277550ethanol 0.72 ML/ML Topical GelSCD4
2277550ethanol 72 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90098-100-012022-01-28C16284748780-1d6a99b39-e438-a426-e053-dadaa90af4c2ac41d70d-0046-783e-e053-2995a90a9a58
90098-100-022022-01-28C16284748780-1d6a99b39-e438-a426-e053-dadaa90af4c2ac41d70d-0046-783e-e053-2995a90a9a58
90098-100-032022-01-28C16284748780-1d6a99b39-e438-a426-e053-dadaa90af4c2ac41d70d-0046-783e-e053-2995a90a9a58
90098-100-042022-01-28C16284748780-1d6a99b39-e438-a426-e053-dadaa90af4c2ac41d70d-0046-783e-e053-2995a90a9a58
90098-100-052022-01-28C16284748780-1d6a99b39-e438-a426-e053-dadaa90af4c2ac41d70d-0046-783e-e053-2995a90a9a58
90098-100-062022-01-28C16284748780-1d6a99b39-e438-a426-e053-dadaa90af4c2ac41d70d-0046-783e-e053-2995a90a9a58
90098-100-072022-01-28C16284748780-1d6a99b39-e438-a426-e053-dadaa90af4c2ac41d70d-0046-783e-e053-2995a90a9a58
90098-100-082022-01-28C16284748780-1d6a99b39-e438-a426-e053-dadaa90af4c2ac41d70d-0046-783e-e053-2995a90a9a58
90098-100-092022-01-28C16284748780-1d6a99b39-e438-a426-e053-dadaa90af4c2ac41d70d-0046-783e-e053-2995a90a9a58

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90098-100-01Hand Sanitizer100 mL in 1 BOTTLEGEL1004
90098-100-02Hand Sanitizer250 mL in 1 BOTTLEGEL2504
90098-100-03Hand Sanitizer500 mL in 1 BOTTLEGEL5004
90098-100-04Hand Sanitizer1000 mL in 1 BOTTLEGEL10004
90098-100-05Hand Sanitizer2000 mL in 1 BOTTLEGEL20004
90098-100-06Hand Sanitizer10000 mL in 1 BOTTLEGEL100004
90098-100-07Hand Sanitizer20000 mL in 1 BOTTLEGEL200004
90098-100-08Hand Sanitizer59 mL in 1 BOTTLEGEL594
90098-100-09Hand Sanitizer20000 mL in 1 BOTTLEGEL200004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90098-100HAND SANITIZER (ALCOHOL) GEL [TRANG LY PHARMA TRADE COMPANY LIMITED]4Legacy NDC, 9 package rows20201015_ac41d70d-0046-783e-e053-2995a90a9a58.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90098-10090098-100-01, 90098-100-02, 90098-100-03, 90098-100-04, 90098-100-05, 90098-100-06, 90098-100-07, 90098-100-08, 90098-100-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
MINTFV98Z8GITPIACT

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
b1b26869-06e7-f77c-e053-2995a90a3b8fac41d70d-0046-783e-e053-2995a90a9a582020-10-15WarningsExact identifier
spl id: b1b26869-06e7-f77c-e053-2995a90a3b8f
spl set id: ac41d70d-0046-783e-e053-2995a90a9a58

Reported adverse events (FAERS/openFDA)#

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