FDA.reportPublic FDA data

ServClean Liquid Hand Sanitizer

Manufacturer
Charlotte Products Ltd
Effective date
2020-09-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:29:01

Label at a glance#

ProductServClean Liquid Hand Sanitizer
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. 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 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

Liquid Hand Sanitizer 500 ML NDC 64646-329-12

Liquid Hand Sanitizer 500 ML NDC 64646-329-12Liquid Hand Sanitizer 500 ML NDC 64646-329-12


Liquid Hand Sanitizer 3.78 Litres NDC 64646-329-04

Liquid Hand Sanitizer 3.78 Litres NDC 64646-329-04Liquid Hand Sanitizer 3.78 Litres NDC 64646-329-04

Liquid Hand Sanitizer 100 ML NDC 64646-329-70

Liquid Hand Sanitizer 100 ML NDC 64646-329-70Liquid Hand Sanitizer 100 ML NDC 64646-329-70

Liquid Hand Sanitizer 100 ML NDC 64646-329-96

Liquid Hand Sanitizer 100 ML NDC 64646-329-96Liquid Hand Sanitizer 100 ML NDC 64646-329-96

Liquid Hand Sanitizer 60ml NDC 64646-329-60

Liquid Hand Sanitizer 60ml NDC 64646-329-60Liquid Hand Sanitizer 60ml NDC 64646-329-60

Liquid Hand Sanitizer 1890 ml NDC 64646-329-19

Liquid Hand Sanitizer 1890 ml NDC 64646-329-19Liquid Hand Sanitizer 1890 ml NDC 64646-329-19

Liquid Hand Sanitizer 750 ml NDC 64646-329-75

Liquid Hand Sanitizer 750 ml NDC 64646-329-75Liquid Hand Sanitizer 750 ml NDC 64646-329-75

Liquid Hand Sanitizer 2 Litres NDC 64646-329-02

Liquid Hand Sanitizer 2 Litres NDC 64646-329-02Liquid Hand Sanitizer 2 Litres NDC 64646-329-02

Liquid Hand Sanitizer 225 ML NDC 64646-329-25

Liquid Hand Sanitizer 225 ML NDC 64646-329-25Liquid Hand Sanitizer 225 ML NDC 64646-329-25

Liquid Hand Sanitizer 3.6 Litres NDC 64646-329-03

Liquid Hand Sanitizer 3.6 Litres NDC 64646-329-03Liquid Hand Sanitizer 3.6 Litres NDC 64646-329-03

Liquid Hand Sanitizer 700 ML NDC 64646-329-07

Liquid Hand Sanitizer 700 ML NDC 64646-329-07Liquid Hand Sanitizer 700 ML NDC 64646-329-07

Liquid Hand Sanitizer Pail 64646-329-20

Liquid Hand Sanitizer Pail 64646-329-20Liquid Hand Sanitizer Pail 64646-329-20

Liquid Hand Sanitizer Drum 64646-329-21

Liquid Hand Sanitizer Drum 64646-329-21Liquid Hand Sanitizer Drum 64646-329-21

Liquid Hand Sanitizer IBC 64646-329-22

Liquid Hand Sanitizer IBC 64646-329-22Liquid Hand Sanitizer IBC 64646-329-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582753ethanol 70 % Topical SolutionPSN2
582753ethanol 0.7 ML/ML Topical SolutionSCD2
582753ethanol 70 % Topical SolutionSY2
582753ethyl alcohol 70 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64646-329-022022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-032022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-042022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-072022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-122022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-192022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-202022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-212022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-222022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-252022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-602022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-702022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-752022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer
64646-329-962022-01-28C16284748780-1d6a99b39-7b33-a426-e053-dadaa90af4c2Liquid Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64646-329-02ServClean Liquid Hand Sanitizer2000 mL in 1 BOTTLE, PLASTICLIQUID20002
64646-329-03ServClean Liquid Hand Sanitizer3600 mL in 1 BOTTLE, PLASTICLIQUID36002
64646-329-04ServClean Liquid Hand Sanitizer3780 mL in 1 BOTTLE, PLASTICLIQUID37802
64646-329-07ServClean Liquid Hand Sanitizer700 mL in 1 BOTTLE, PLASTICLIQUID7002
64646-329-12ServClean Liquid Hand Sanitizer500 mL in 1 BOTTLE, PLASTICLIQUID5002
64646-329-19ServClean Liquid Hand Sanitizer1890 mL in 1 BOTTLE, PLASTICLIQUID18902
64646-329-20ServClean Liquid Hand Sanitizer18900 mL in 1 PAILLIQUID189002
64646-329-21ServClean Liquid Hand Sanitizer208000 mL in 1 DRUMLIQUID2080002
64646-329-22ServClean Liquid Hand Sanitizer1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKLIQUID10000002
64646-329-25ServClean Liquid Hand Sanitizer225 mL in 1 BOTTLE, PLASTICLIQUID2252
64646-329-60ServClean Liquid Hand Sanitizer60 mL in 1 BOTTLE, PLASTICLIQUID602
64646-329-70ServClean Liquid Hand Sanitizer100 mL in 1 BOTTLE, PLASTICLIQUID1002
64646-329-75ServClean Liquid Hand Sanitizer750 mL in 1 BOTTLE, PLASTICLIQUID7502
64646-329-96ServClean Liquid Hand Sanitizer100 mL in 1 BOTTLE, PLASTICLIQUID1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64646-329SERVCLEAN LIQUID HAND SANITIZER (ALCOHOL) LIQUID [CHARLOTTE PRODUCTS LTD]2Legacy NDC, 14 package rows20200911_a6ceace2-ed87-c5b1-e053-2a95a90a164b.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
64646-32964646-329-70, 64646-329-12, 64646-329-04, 64646-329-96, 64646-329-60, 64646-329-19, 64646-329-75, 64646-329-02, 64646-329-25, 64646-329-03, 64646-329-07, 64646-329-20, 64646-329-22, 64646-329-21

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
af022842-11b3-5dce-e053-2995a90a584ca6ceace2-ed87-c5b1-e053-2a95a90a164b2020-09-10WarningsExact identifier
spl id: af022842-11b3-5dce-e053-2995a90a584c
spl set id: a6ceace2-ed87-c5b1-e053-2a95a90a164b

Reported adverse events (FAERS/openFDA)#

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