FDA.reportPublic FDA data

Theochem Tea Tree Hand and Body Wash

Manufacturer
Theochem Laboratories
Effective date
2013-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:22

Label at a glance#

ProductTheochem Tea Tree Hand and Body Wash
Active ingredientTRICLOSAN
Label structure9 sections

Indications and uses

For Hand Washing, and to decrease bacteria on the skin. Recommended for repeated use.

Dosage and administration

For use with Dispenser: Pour contents into the dispenser reservoir. For first use applications, pump dispenser a few times to prime. For use as Hand Soap: Wet hands and dispense a small amount of the product into palm. Rub hands to produce lather. Rinse thoroughly with water, then dry hands completely. For use as Bath and Body Wash: Apply sparingly. Avoid contact with eyes. Lather and rinse.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Triclosan 0.2%

Purpose:

OTC - PURPOSE SECTION

Antimicrobial

Uses:

INDICATIONS & USAGE SECTION

For Hand Washing, and to decrease bacteria on the skin.

Recommended for repeated use.

Warnings:

WARNINGS SECTION

For external use only.

When using this product, do not get into eyes. If contact occurs, rinse eyes thoroughly with water

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

For use with Dispenser:

Pour contents into the dispenser reservoir. For first use applications, pump dispenser a few times to prime.

For use as Hand Soap:

Wet hands and dispense a small amount of the product into palm. Rub hands to produce lather. Rinse thoroughly with water, then dry hands completely.

For use as Bath and Body Wash:

Apply sparingly. Avoid contact with eyes. Lather and rinse.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature. Avoid extremes of both hot and cold.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Water, Sodium Lauryl Sulfate, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Tetrasodium Salt of Ethylenediamine Tetraacetic Acid, Glycerine, Propylene Glycol, Aloe Extract, FD&C Blue # 1, FD&C Yellow # 5, Fragrance, 1,2-benzisothiazolin-3-one and 2-methyl-4-isothiazolin-3-one.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TEA TREE HAND & BODY WASH

NET CONTENTS: ONE GALLON (3.785 LITERS)

TEA TREE FRONT PANELTEA TREE FRONT PANEL

TEA TREE BACK PANELTEA TREE BACK PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
413246triclosan 0.2 % Medicated Liquid SoapPSN1
413246triclosan 2 MG/ML Medicated Liquid SoapSCD1
413246triclosan 0.2 % Medicated Liquid SoapSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68878-120-202019-11-27C16284748780-19855e2a2-49c5-60a7-e053-dbdaa90a05bdTea Tree Hand and Body Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68878-120-11Theochem Tea Tree Hand and Body Wash3.785 L in 1 BOTTLE, PLASTICSOAP3.7851
68878-120-20Theochem Tea Tree Hand and Body Wash2 in 1 CASESOAP21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68878-120THEOCHEM TEA TREE HAND AND BODY WASH (TEA TREE HAND AND BODY WASH) SOAP [THEOCHEM LABORATORIES]1Legacy NDC, 2 package rows20131105_ce1db79c-20ce-47b8-95fd-0989acd6605b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5X1
TRICLOSANACTIVE MOIETY4NM5039Y5X1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68878-12068878-120-11, 68878-120-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRICLOSAN4NM5039Y5XACTIB
WATER059QF0KO0RIACT

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
c9a39a32-00de-42f0-ba65-c1ee1ce214cace1db79c-20ce-47b8-95fd-0989acd6605b2013-10-03WarningsExact identifier
spl id: c9a39a32-00de-42f0-ba65-c1ee1ce214ca
spl set id: ce1db79c-20ce-47b8-95fd-0989acd6605b

Reported adverse events (FAERS/openFDA)#

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