FDA.reportPublic FDA data

Enviro Solutions Gel Hand Sanitizer

Manufacturer
Charlotte Products Ltd.
Effective date
2021-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:21

Label at a glance#

ProductHand 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 (0.12% v/v).
  4. DI water.
  5. Acrylates crosspolymer
  6. 2,4-D diethylethanolamine

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, acrylates crosspolymer, 2,4-D diethylethanolamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1250 mL NDC: 64646-043-04

Es43 1250ml labelEs43 1250ml label500 ml NDC: 64646-043-12

ES43 500ml labelES43 500ml label2L NDC:64646-043-02

ES43 2 L labelES43 2 L label3.78L NDC: 64646-043-03

ES43 3.78L LabelES43 3.78L Label18.9L NDC: 64646-043-20

ES43 18.9 L labelES43 18.9 L label55L NDC: 64646-043-21

ES43 55L labelES43 55L label208L NDC: 64646-04-22

ES43 208 L LabelES43 208 L Label1000L NDC: 64646-043-23

ES43 1000L labelES43 1000L label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2282911ethanol 71 % Topical GelPSN1
2282911ethanol 0.71 ML/ML Topical GelSCD1
2282911ethanol 71 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64646-043-022023-01-30C16284748780-1f386c649-b72d-0266-e053-dadaa90a7c1aEnviro Solutions Gel Hand Sanitizer
64646-043-032023-01-30C16284748780-1f386c649-b72d-0266-e053-dadaa90a7c1aEnviro Solutions Gel Hand Sanitizer
64646-043-042023-01-30C16284748780-1f386c649-b72d-0266-e053-dadaa90a7c1aEnviro Solutions Gel Hand Sanitizer
64646-043-122023-01-30C16284748780-1f386c649-b72d-0266-e053-dadaa90a7c1aEnviro Solutions Gel Hand Sanitizer
64646-043-202023-01-30C16284748780-1f386c649-b72d-0266-e053-dadaa90a7c1aEnviro Solutions Gel Hand Sanitizer
64646-043-212023-01-30C16284748780-1f386c649-b72d-0266-e053-dadaa90a7c1aEnviro Solutions Gel Hand Sanitizer
64646-043-222023-01-30C16284748780-1f386c649-b72d-0266-e053-dadaa90a7c1aEnviro Solutions Gel Hand Sanitizer
64646-043-232023-01-30C16284748780-1f386c649-b72d-0266-e053-dadaa90a7c1aEnviro Solutions Gel Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64646-043-02Hand Sanitizer2000 mL in 1 BOTTLEGEL20001
64646-043-03Hand Sanitizer37800 mL in 1 BOTTLEGEL378001
64646-043-04Hand Sanitizer1250 mL in 1 BOTTLE, DISPENSINGGEL12501
64646-043-12Hand Sanitizer500 mL in 1 BOTTLE, PUMPGEL5001
64646-043-20Hand Sanitizer18900 mL in 1 PAILGEL189001
64646-043-21Hand Sanitizer55000 mL in 1 DRUMGEL550001
64646-043-22Hand Sanitizer208000 mL in 1 DRUMGEL2080001
64646-043-23Hand Sanitizer1000 mL in 1 DRUMGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64646-043HAND SANITIZER (ALCOHOL) GEL [CHARLOTTE PRODUCTS LTD.]1Legacy NDC, 8 package rows20210911_cb09877c-fb37-394c-e053-2995a90a15d8.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
64646-04364646-043-04, 64646-043-12, 64646-043-03, 64646-043-20, 64646-043-21, 64646-043-22, 64646-043-23, 64646-043-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
2,4-D DIETHYLETHANOLAMINES070272I1TIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT

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
cb097d2d-bdf0-5939-e053-2995a90afca8cb09877c-fb37-394c-e053-2995a90a15d82021-09-02WarningsExact identifier
spl id: cb097d2d-bdf0-5939-e053-2995a90afca8
spl set id: cb09877c-fb37-394c-e053-2995a90a15d8

Reported adverse events (FAERS/openFDA)#

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