FDA.reportPublic FDA data

Clear Defense Hand Gel

Manufacturer
Melaleuca, Inc. | Melaleuca - TN
Effective date
2025-04-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:58:46

Label at a glance#

ProductClear Defense
Active ingredientALCOHOL
Label structure12 sections

Storage and handling

Other information store below 82°F (28°C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Ethyl Alcohol 62%

OTC - PURPOSE SECTION

Purpose
Antimicrobial

INDICATIONS & USAGE SECTION

Uses

  • to reduce bacteria on the skin
  • recommended for repeated use

WARNINGS SECTION

Warnings
For External use only
Highly flammable. Keep away from fire or flame.

OTC - DO NOT USE SECTION

Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash appears and lasts.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • dispense a generous amount of gel in your palm
  • spread gel over your hands until thoroughly coated
  • rub your hands together briskly until dry
  • children under 6 should be supervised when using this product

STORAGE AND HANDLING SECTION

Other information

  • store below 82°F (28°C)

PRECAUTIONS SECTION

Other information

  • may discolor certain fabrics or surfaces

INACTIVE INGREDIENT SECTION

Inactive ingredients
water, glycerin, xylitol, anhydroxylitol, xylitylglucoside, carbomer, aminomethyl propanol, fragrance, aloe barbadensis leaf extract, melaleuca alternifolia (tea tree) leaf oil, polysorbate 20, tocopheryl acetate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54473-311-092025-04-07C16284748780-12cef2736-a1f0-d83d-e063-dadaa90ab31fClear Defense Hand Gel
54473-311-162025-04-07C16284748780-12cef2736-a1f0-d83d-e063-dadaa90ab31fClear Defense Hand Gel
54473-311-182025-04-07C16284748780-12cef2736-a1f0-d83d-e063-dadaa90ab31fClear Defense Hand Gel
54473-311-242025-04-07C16284748780-12cef2736-a1f0-d83d-e063-dadaa90ab31fClear Defense Hand Gel
54473-311-092025-01-30C16284748780-12cef2736-a1f0-d83d-e063-dadaa90ab31fClear Defense Hand Gel
54473-311-162025-01-30C16284748780-12cef2736-a1f0-d83d-e063-dadaa90ab31fClear Defense Hand Gel
54473-311-182025-01-30C16284748780-12cef2736-a1f0-d83d-e063-dadaa90ab31fClear Defense Hand Gel
54473-311-242025-01-30C16284748780-12cef2736-a1f0-d83d-e063-dadaa90ab31fClear Defense Hand Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54473-311-09Clear Defense266 mL in 1 BOTTLEGEL2663
54473-311-16Clear Defense473 mL in 1 BOTTLEGEL4733
54473-311-18Clear Defense53 mL in 1 BOTTLEGEL533
54473-311-24Clear Defense71 mL in 1 BOTTLEGEL713

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54473-311CLEAR DEFENSE (ETHYL ALCOHOL) GEL [MELALEUCA, INC.]3Current NDC, Legacy NDC, 4 package rows20250409_a2178a68-780e-e69b-e053-2a95a90ab7d6.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54473-31154473-311-09, 54473-311-24, 54473-311-16, 54473-311-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYSORBATE 207T1F30V5YHIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALCOHOL3K9958V90MACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
AMINOMETHYLPROPANOLLU49E6626QIACT

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
Clear DefenseETHYL ALCOHOLMelaleuca, Inc.a2178a68-780e-e69b-e053-2a95a90ab7d62025-04-02WarningsExact identifier
ndc (package): 54473-311-24
ndc (package): 54473-311-09
ndc (package): 54473-311-16
ndc (package): 54473-311-18
ndc (product): 54473-311
ndc11 (package): 54473031124
ndc11 (package): 54473031118
ndc11 (package): 54473031116
ndc11 (package): 54473031109
spl id: 31ce46cd-0dc8-8d08-e063-6294a90af45a
spl set id: a2178a68-780e-e69b-e053-2a95a90ab7d6

Reported adverse events (FAERS/openFDA)#

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