FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
RANG DONG S.P.CA MANUFACTURING - CONSTRUCTION - TRADING COMPANY LIMITED
Effective date
2020-10-15
Label type
HUMAN OTC DRUG LABEL
Version
2
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

Get a sufficient amount of products onto hands. Brisky rub hands together until dry. Supervise children under 6 years old in the use of this product.

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. 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

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin. 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

  • Get a sufficient amount of products onto hands.
  • Brisky rub hands together until dry.
  • Supervise children under 6 years old in the use of this product.

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

RECENT MAJOR CHANGES SECTION

Use: Updated from template to actual label wording. Same meaning.

Direction: Updated from template to actual label wording. Same meaning.

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

29.5 mL NDC: 80060-100-01

80060-100-0180060-100-01

59 mL NDC: 80060-100-02

80060-100-0280060-100-02

88.5 mL NDC: 80060-100-03

80060-100-0380060-100-03

118 mL NDC: 80060-100-04

80060-100-0480060-100-04

236.59 mL NDC: 80060-100-05

80060-100-0580060-100-05

295 mL NDC: 80060-100-06

80060-100-0680060-100-06

354 mL NDC: 80060-100-07

80060-100-0780060-100-07

500 mL NDC: 80060-100-08

80060-100-0880060-100-08

590 mL NDC: 80060-100-09

80060-100-0980060-100-09

975 mL NDC: 80060-100-10

80060-100-1080060-100-10

5000 mL NDC: 80060-100-11

80060-100-1180060-100-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN2
1041498ethanol 0.8 ML/ML Topical GelSCD2
1041498ethanol 80 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80060-100-012022-01-28C16284748780-1d6a99b39-cb06-a426-e053-dadaa90af4c2ac920fa7-4840-1793-e053-2995a90a8cd0
80060-100-022022-01-28C16284748780-1d6a99b39-cb06-a426-e053-dadaa90af4c2ac920fa7-4840-1793-e053-2995a90a8cd0
80060-100-032022-01-28C16284748780-1d6a99b39-cb06-a426-e053-dadaa90af4c2ac920fa7-4840-1793-e053-2995a90a8cd0
80060-100-042022-01-28C16284748780-1d6a99b39-cb06-a426-e053-dadaa90af4c2ac920fa7-4840-1793-e053-2995a90a8cd0
80060-100-052022-01-28C16284748780-1d6a99b39-cb06-a426-e053-dadaa90af4c2ac920fa7-4840-1793-e053-2995a90a8cd0
80060-100-062022-01-28C16284748780-1d6a99b39-cb06-a426-e053-dadaa90af4c2ac920fa7-4840-1793-e053-2995a90a8cd0
80060-100-072022-01-28C16284748780-1d6a99b39-cb06-a426-e053-dadaa90af4c2ac920fa7-4840-1793-e053-2995a90a8cd0
80060-100-082022-01-28C16284748780-1d6a99b39-cb06-a426-e053-dadaa90af4c2ac920fa7-4840-1793-e053-2995a90a8cd0
80060-100-092022-01-28C16284748780-1d6a99b39-cb06-a426-e053-dadaa90af4c2ac920fa7-4840-1793-e053-2995a90a8cd0
80060-100-102022-01-28C16284748780-1d6a99b39-cb06-a426-e053-dadaa90af4c2ac920fa7-4840-1793-e053-2995a90a8cd0
80060-100-112022-01-28C16284748780-1d6a99b39-cb06-a426-e053-dadaa90af4c2ac920fa7-4840-1793-e053-2995a90a8cd0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80060-100-01Hand Sanitizer29.5 mL in 1 BOTTLEGEL29.52
80060-100-02Hand Sanitizer59 mL in 1 BOTTLEGEL592
80060-100-03Hand Sanitizer88.5 mL in 1 BOTTLEGEL88.52
80060-100-04Hand Sanitizer118 mL in 1 BOTTLEGEL1182
80060-100-05Hand Sanitizer236.59 mL in 1 BOTTLEGEL236.592
80060-100-06Hand Sanitizer295 mL in 1 BOTTLEGEL2952
80060-100-07Hand Sanitizer354 mL in 1 BOTTLEGEL3542
80060-100-08Hand Sanitizer500 mL in 1 BOTTLEGEL5002
80060-100-09Hand Sanitizer590 mL in 1 BOTTLEGEL5902
80060-100-10Hand Sanitizer975 mL in 1 BOTTLEGEL9752
80060-100-11Hand Sanitizer5000 mL in 1 BOTTLEGEL50002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80060-100HAND SANITIZER (ALCOHOL) GEL [RANG DONG S.P.CA MANUFACTURING - CONSTRUCTION - TRADING COMPANY LIMITED]2Legacy NDC, 11 package rows20201015_ac920fa7-4840-1793-e053-2995a90a8cd0.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
80060-10080060-100-01, 80060-100-02, 80060-100-03, 80060-100-04, 80060-100-05, 80060-100-06, 80060-100-07, 80060-100-08, 80060-100-09, 80060-100-10, 80060-100-11

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

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
b1b282ae-52d5-2c5c-e053-2a95a90ab948ac920fa7-4840-1793-e053-2995a90a8cd02020-10-15WarningsExact identifier
spl id: b1b282ae-52d5-2c5c-e053-2a95a90ab948
spl set id: ac920fa7-4840-1793-e053-2995a90a8cd0

Reported adverse events (FAERS/openFDA)#

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