FDA.reportPublic FDA data

Green World Hand Skin Sanitiser

Manufacturer
LIDER KOZMETIK
Effective date
2022-01-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:55

Label at a glance#

ProductGreen World Hand Skin Sanitiser
Active ingredientBENZALKONIUM CHLORIDE, ALCOHOL
Label structure13 sections

Dosage and administration

Put enough product in your palm to cover hands and Rub hands together briskly 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) May discolor certain fabrics or surface.

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) (74.8%,weight/volume (w/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Benzalkonium Chloride 0.1 % /w/v)
  3. Glycerol
  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 74.8% w/v. Benzalkonium chloride 0.1 % ( w/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 liquid and vapor. 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

  • Put enough product in your palm to cover hands and Rub hands together briskly 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)
  • May discolor certain fabrics or surface.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

150 mL NDC: 86966-003-01

150 ml150 ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
86966-003-012024-01-30C16284748780-1d6a99b39-99ea-a426-e053-dadaa90af4c2Green World Hand&Skin Sanitiser
86966-003-012022-02-02C16284748780-1d6a99b39-99ea-a426-e053-dadaa90af4c2Green World Hand&Skin Sanitiser
86966-003-012022-01-28C16284748780-1d6a99b39-99ea-a426-e053-dadaa90af4c2Green World Hand&Skin Sanitiser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
86966-003-01Green World Hand Skin Sanitiser150 mL in 1 BOTTLE, SPRAYSPRAY1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
86966-003GREEN WORLD HAND SKIN SANITISER (ETHYL ALCOHOL, BENZALKONIUM CHLORIDE) SPRAY [LIDER KOZMETIK]2Legacy NDC, 1 package rows20220203_b689df1b-e0e3-0708-e053-2a95a90a2422.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
86966-00386966-003-01

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
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
d647ca92-bbda-e1db-e053-2a95a90aaafab689df1b-e0e3-0708-e053-2a95a90a24222022-01-23WarningsExact identifier
spl id: d647ca92-bbda-e1db-e053-2a95a90aaafa
spl set id: b689df1b-e0e3-0708-e053-2a95a90a2422

Reported adverse events (FAERS/openFDA)#

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