Tea Tree Antiseptic

Manufacturer: Integria Healthcare US Inc. | Integria Healthcare (Ballina)
Effective date: 2011-03-17
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:27:29

Label at a glance#

ProductTea Tree Antiseptic

Active ingredientTEA TREE OIL

Label structure11 sections

Storage and handling

store below 86 degrees F

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Melaleuca Alternifolia (Tea Tree) Leaf Oil 5%

OTC - PURPOSE SECTION

Antiseptic

INDICATIONS & USAGE SECTION

protects cuts, abrasions, cracked dry skin, chapped lips and other minor wounds against infection

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

OTC - STOP USE SECTION

Stop use and ask a doctor if redness, irritation or pain persists or increases, or if infection occurs.

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

clean the affected area
apply small amount two or three times a day
may be covered with a sterile bandage

STORAGE AND HANDLING SECTION

store below 86 degrees F

INACTIVE INGREDIENT SECTION

Beeswax, Canola Oil, Copernicia Cerifera (Carnauba) Wax, Macadamia Integrifolia Seed Oil, Tocopherol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tea Tree Antiseptic Ointment Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51257-644-01	2019-10-29	C162847	48780-1	960f7f55-bf93-8e05-e053-dbdaa90a074a	9534eb1d-89a7-4922-a121-742aa5418416

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51257-644-01	Tea Tree Antiseptic	50 g in 1 JAR	OINTMENT	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51257-644	TEA TREE ANTISEPTIC (MELALEUCA ALTERNIFOLIA) OINTMENT [INTEGRIA HEALTHCARE US INC.]	1	Legacy NDC, 1 package rows	20110318_9534eb1d-89a7-4922-a121-742aa5418416.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TEA TREE OIL	ACTIVE INGREDIENT	VIF565UC2G	1
TEA TREE OIL	ACTIVE MOIETY	VIF565UC2G	1
CANOLA OIL	INACTIVE INGREDIENT	331KBJ17RK	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	1
MACADAMIA OIL	INACTIVE INGREDIENT	515610SU8C	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	1

Products#

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

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

Tea Tree Antiseptic
Melaleuca Alternifolia
TEA TREE OIL
YELLOW WAX
CANOLA OIL
CARNAUBA WAX
MACADAMIA OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51257-644	51257-644-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TEA TREE OIL	VIF565UC2G	ACTIB
YELLOW WAX	2ZA36H0S2V	IACT
CANOLA OIL	331KBJ17RK	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
MACADAMIA OIL	515610SU8C	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, DELAYED RELEASE / ORAL	230 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	CAPSULE / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET / ORAL	167.8 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET / ORAL	3.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE, EXTENDED RELEASE / ORAL	80.67 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, EXTENDED RELEASE / ORAL		2150 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, COATED / ORAL	213.7 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	GUM, CHEWING / BUCCAL		10 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, DELAYED RELEASE / ORAL	0.1 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CAPSULE / ORAL		44 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	CAPSULE, EXTENDED RELEASE / ORAL		288 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	140 mg		Exact identifier — unii candidate 11 equally ranked IID candidates
CARNAUBA WAX	CARNAUBA WAX	R12CBM0EIZ	TABLET, FILM COATED / ORAL		1 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
YELLOW WAX	YELLOW WAX	2ZA36H0S2V	OINTMENT / TOPICAL	20 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
58bedeaa-78d7-4baa-9810-ea7be458dd3c			9534eb1d-89a7-4922-a121-742aa5418416	2011-03-17	Warnings	Exact identifier spl id: 58bedeaa-78d7-4baa-9810-ea7be458dd3c spl set id: 9534eb1d-89a7-4922-a121-742aa5418416

Reported adverse events (FAERS/openFDA)#

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