FDA.reportPublic FDA data

Practical Care Hand Sanitizer

Manufacturer
Lindie Nzie Trading and Business Services
Effective date
2020-08-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:25:18

Label at a glance#

ProductPractical Care Hand Sanitizer
Active ingredientALCOHOL
Label structure12 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#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 70% 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 and Information Panel 1 Liter

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1000 mL PDD and Information Panel1000 mL PDD and Information Panel1000 mL NDC: 77682-001-02

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77682-001-022022-01-28C16284748780-1d6a99b39-fa9b-a426-e053-dadaa90af4c2Hand Sanitizer
77682-001-032022-01-28C16284748780-1d6a99b39-fa9b-a426-e053-dadaa90af4c2Hand Sanitizer
77682-001-042022-01-28C16284748780-1d6a99b39-fa9b-a426-e053-dadaa90af4c2Hand Sanitizer
77682-001-052022-01-28C16284748780-1d6a99b39-fa9b-a426-e053-dadaa90af4c2Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77682-001-02Practical Care Hand Sanitizer1000 mL in 1 BOTTLELIQUID10004
77682-001-03Practical Care Hand Sanitizer60 mL in 1 BOTTLELIQUID604
77682-001-04Practical Care Hand Sanitizer500 mL in 1 BOTTLELIQUID5004
77682-001-05Practical Care Hand Sanitizer5000 mL in 1 BOTTLELIQUID50004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77682-001PRACTICAL CARE HAND SANITIZER (ETHYL ALCOHOL) LIQUID [LINDIE NZIE TRADING AND BUSINESS SERVICES]4Legacy NDC, 4 package rows20200821_a7da75b3-b546-641c-e053-2995a90a43b7.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
77682-00177682-001-02, 77682-001-03, 77682-001-04, 77682-001-05

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
ALCOHOL3K9958V90MACTIB
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT

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
ad59647c-0062-1902-e053-2995a90a28b0a7da75b3-b546-641c-e053-2995a90a43b72020-08-20WarningsExact identifier
spl id: ad59647c-0062-1902-e053-2995a90a28b0
spl set id: a7da75b3-b546-641c-e053-2995a90a43b7

Reported adverse events (FAERS/openFDA)#

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