FDA.reportPublic FDA data

ServClean Gel Hand Sanitizer

Manufacturer
Charlotte Products Ltd | Charlotte Products
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 Gel 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 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gel Hand Sanitizer 500ml NDC 64646-328-12 Gel Hand Sanitizer 500 ML NDC 64646-328-12Gel Hand Sanitizer 500 ML NDC 64646-328-12

Gel Hand Sanitizer 2 Litres NDC 64646-328-02

Gel Hand Sanitizer 2 Litres NDC 64646-328-02Gel Hand Sanitizer 2 Litres NDC 64646-328-02

Gel Hand Sanitizer 225 ML NDC 64646-328-25

Gel Hand Sanitizer 225 ML NDC 64646-328-25Gel Hand Sanitizer 225 ML NDC 64646-328-25

Gel Hand Sanitizer 3.6 Litres NDC 64646-328-03

Gel Hand Sanitizer 3.6 Litres NDC 64646-328-03Gel Hand Sanitizer 3.6 Litres NDC 64646-328-03
Gel Hand Sanitizer 3.78 Litres NDC 64646-328-04

Gel Hand Sanitizer 3.78 Litres NDC 64646-328-04Gel Hand Sanitizer 3.78 Litres NDC 64646-328-04


Gel Hand Sanitizer 700 ML NDC 64646-328-07

Gel Hand Sanitizer 700 ML NDC 64646-328-07Gel Hand Sanitizer 700 ML NDC 64646-328-07

Gel Hand Sanitizer 100 ML NDC 64646-328-70

Gel Hand Sanitizer 100 ML NDC 64646-328-25Gel Hand Sanitizer 100 ML NDC 64646-328-25


Gel Hand Sanitizer 60ml NDC 64646-328-60

Gel Hand Sanitizer 60ml NDC 64646-328-60Gel Hand Sanitizer 60ml NDC 64646-328-60

Gel Hand Sanitizer 1890 ml NDC 64646-328-19

Gel Hand Sanitizer 1890 ml NDC 64646-328-19Gel Hand Sanitizer 1890 ml NDC 64646-328-19


Gel Hand Sanitizer 750 ml NDC 64646-328-75

Gel Hand Sanitizer 750 ml NDC 64646-328-75Gel Hand Sanitizer 750 ml NDC 64646-328-75

Gel 18.9L pail 64646-328-20

Gel 18.9L pail 64646-328-20Gel 18.9L pail 64646-328-20

Gel 208L drum 64646-328-21

Gel 208L drum 64646-328-21Gel 208L drum 64646-328-21

Gel 1000L IBC 64646-328-22

Gel 1000L IBC 64646-328-22Gel 1000L IBC 64646-328-22

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64646-328-022022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-032022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-042022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-072022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-122022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-192022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-202022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-212022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-222022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-252022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-602022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-702022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel
64646-328-752022-01-28C16284748780-1d6a99b39-fb7d-a426-e053-dadaa90af4c2Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64646-328-02ServClean Gel Hand Sanitizer2000 mL in 1 BOTTLE, PLASTICGEL20002
64646-328-03ServClean Gel Hand Sanitizer3600 mL in 1 BOTTLE, PLASTICGEL36002
64646-328-04ServClean Gel Hand Sanitizer3780 mL in 1 BOTTLE, PLASTICGEL37802
64646-328-07ServClean Gel Hand Sanitizer700 mL in 1 BOTTLE, PLASTICGEL7002
64646-328-12ServClean Gel Hand Sanitizer500 mL in 1 BOTTLE, PLASTICGEL5002
64646-328-19ServClean Gel Hand Sanitizer1890 mL in 1 BOTTLE, PLASTICGEL18902
64646-328-20ServClean Gel Hand Sanitizer18900 mL in 1 PAILGEL189002
64646-328-21ServClean Gel Hand Sanitizer208000 mL in 1 DRUMGEL2080002
64646-328-22ServClean Gel Hand Sanitizer1000000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKGEL10000002
64646-328-25ServClean Gel Hand Sanitizer225 mL in 1 BOTTLE, PLASTICGEL2252
64646-328-60ServClean Gel Hand Sanitizer60 mL in 1 BOTTLE, PLASTICGEL602
64646-328-70ServClean Gel Hand Sanitizer100 mL in 1 BOTTLE, PLASTICGEL1002
64646-328-75ServClean Gel Hand Sanitizer750 mL in 1 BOTTLE, PLASTICGEL7502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64646-328SERVCLEAN GEL HAND SANITIZER (ALCOHOL) GEL [CHARLOTTE PRODUCTS LTD]2Legacy NDC, 13 package rows20200911_a67b3c1c-c221-4b25-e053-2a95a90a3d0b.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
64646-32864646-328-75, 64646-328-12, 64646-328-02, 64646-328-25, 64646-328-03, 64646-328-04, 64646-328-07, 64646-328-70, 64646-328-60, 64646-328-19, 64646-328-22, 64646-328-21, 64646-328-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9404Q93RCW27EIACT
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
af01da51-ae63-2fe1-e053-2a95a90a1b7ca67b3c1c-c221-4b25-e053-2a95a90a3d0b2020-09-10WarningsExact identifier
spl id: af01da51-ae63-2fe1-e053-2a95a90a1b7c
spl set id: a67b3c1c-c221-4b25-e053-2a95a90a3d0b

Reported adverse events (FAERS/openFDA)#

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