ServClean Gel Hand Sanitizer

Manufacturer
Charlotte Products Ltd.
Effective date
2024-07-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:15:54

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) (71%, 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. Distilled water.
  5. 2,4-D diethylethanolamine
  6. acrylates crosspolymer

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 71% 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

1250 ml label1250 ml label1250 mL NDC: 64646-380-04

500ml label500ml label500ml NDC:64646-380-12

2000 mL label2000 mL label

2L NDC:64646-380-02

3.78L label3.78L label3.78 NDC:64646-380-03

18.9 L label18.9 L label18.9 L NDC:64646-380-20

55L label55L label55L NDC:64646-380-21

208 L label208 L label208L NDC:64646-380-22

1000L label1000L label1000L NDC:64646-380-23

ES43 1250 mlES43 1250 ml1250 mL NDC: 64646-043-04

ES43 500 ml labelES43 500 ml label500 mL NDC:64646-043-12

ES43 2L labelES43 2L label2L NDC:64646-043-02

ES43 3.78 L labelES43 3.78 L label3.78L NDC:64646-043-03

ES43 18.9L labelES43 18.9L label18.9 L NDC: 64646-043-20

ES43 55 L labelES43 55 L label55 L NDC: 64646-043-21

ES43 208L labelES43 208L label208L NDC: 64646-043-22

ES43 1000 L LabelES43 1000 L Label1000L NDC: 64646-043-23

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2282911ethanol 71 % Topical GelPSN2
2282911ethanol 0.71 ML/ML Topical GelSCD2
2282911ethanol 71 % Topical GelSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64646-380-022024-07-22C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-032024-07-22C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-042024-07-22C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-122024-07-22C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-202024-07-22C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-212024-07-22C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-222024-07-22C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-232024-07-22C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-022023-01-30C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-032023-01-30C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-042023-01-30C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-122023-01-30C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-202023-01-30C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-212023-01-30C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-222023-01-30C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer
64646-380-232023-01-30C16284748780-1f386c64a-4310-0266-e053-dadaa90a7c1aSC Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64646-380-02ServClean Gel Hand Sanitizer2000 mL in 1 BOTTLEGEL20002
64646-380-03ServClean Gel Hand Sanitizer3780 mL in 1 BOTTLEGEL37802
64646-380-04ServClean Gel Hand Sanitizer1250 mL in 1 BOTTLE, DISPENSINGGEL12502
64646-380-12ServClean Gel Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5002
64646-380-20ServClean Gel Hand Sanitizer18900 mL in 1 PAILGEL189002
64646-380-21ServClean Gel Hand Sanitizer55000 mL in 1 DRUMGEL550002
64646-380-22ServClean Gel Hand Sanitizer208000 mL in 1 DRUMGEL2080002
64646-380-23ServClean Gel Hand Sanitizer1000000 mL in 1 DRUMGEL10000002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64646-380SERVCLEAN GEL HAND SANITIZER (ALCOHOL) GEL [CHARLOTTE PRODUCTS LTD.]2Legacy NDC, 8 package rows20240724_caf4dba6-db03-2a91-e053-2995a90a8d69.zip

Products#

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

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

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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
1dda6f12-edb1-a5cc-e063-6394a90ae078caf4dba6-db03-2a91-e053-2995a90a8d692024-07-22WarningsExact identifier
spl id: 1dda6f12-edb1-a5cc-e063-6394a90ae078
spl set id: caf4dba6-db03-2a91-e053-2995a90a8d69

Reported adverse events (FAERS/openFDA)#

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