FDA.reportPublic FDA data

McClains Extra Strength And Moisture Hand Sanitizer Original

Manufacturer
McClain's Health LLC
Effective date
2020-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:36:00

Label at a glance#

ProductMcClains Extra Strength And Moisture Hand Sanitizer Original
Active ingredientISOPROPYL ALCOHOL
Label structure14 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry.

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

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 CDC recommendations:

  1. Isopropyl Alcohol (75%, 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. Sterile distilled water or boiled cold water.

Formulation:

FormulationFormulation

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Active IngredientsActive Ingredients

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

PurposePurpose

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria on the skin.

UsageUsage

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

WarningWarning

Do not use

OTC - DO NOT USE SECTION

  • keep out of reach of children
  • do not use in or near the eyes

Do Not UseDo Not Use

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.

When UsingWhen Using

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Stop UseStop Use

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.

Keep Out Of Reach Of ChildrenKeep Out Of Reach Of Children

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.

InstructionsInstructions

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

StorageStorage

Inactive ingredients

INACTIVE INGREDIENT SECTION

USP Purified Water, Organic Aloe Leaf Juice, Phenoxyethanol, Glycerin, Withc Hazel Water, Alcohol, Carbomer, Triethanolamine, Tetrasodium Glutamate Diacetate, Essential Oils.

Inactive IngredientsInactive Ingredients

RECENT MAJOR CHANGES SECTION

- Changed usage to reflect exact wording on label.

- Added image of instructions to Dosage form

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 ml NDC: 81150-001-01

Principal DisplayPrincipal Display

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN1
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD1
1039900isopropyl alcohol 75 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81150-001-012022-01-28C16284748780-1d6a99b39-4d43-a426-e053-dadaa90af4c2Hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81150-001-01McClains Extra Strength And Moisture Hand Sanitizer Original59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81150-001MCCLAINS EXTRA STRENGTH AND MOISTURE HAND SANITIZER ORIGINAL (ISOPROPYL ALCOHOL) LIQUID [MCCLAIN'S HEALTH LLC]1Legacy NDC, 1 package rows20201229_b4479e85-eee4-8577-e053-2a95a90ad3d8.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81150-00181150-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEMON OILI9GRO824LLIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
CINNAMON OILE5GY4I6YCZIACT
ROSEMARY OIL8LGU7VM393IACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
WITCH HAZEL101I4J0U34IACT
CARBOMER 9404Q93RCW27EIACT
CLOVE OIL578389D6D0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALCOHOL3K9958V90MIACT

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
b4479e85-eed6-8577-e053-2a95a90ad3d8b4479e85-eee4-8577-e053-2a95a90ad3d82020-11-19WarningsExact identifier
spl id: b4479e85-eed6-8577-e053-2a95a90ad3d8
spl set id: b4479e85-eee4-8577-e053-2a95a90ad3d8

Reported adverse events (FAERS/openFDA)#

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