Muscle and Joint Heat Cream

Manufacturer
Ultra Mix (Aust) Pty Ltd
Effective date
2016-04-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:45:47

Label at a glance#

ProductMuscle and Joint Heat Cream
Active ingredientEUCALYPTUS OIL, TEA TREE OIL, METHYL SALICYLATE
Label structure6 sections

Dosage and administration

Apply a small amount of Muscle and Joint Heat Cream to the affected area and massage in until fully absorbed. Use twice daily or more frequently if required.

Label contents#

Full prescribing information#

Actives

OTC - ACTIVE INGREDIENT SECTION

Tea Tree Oil (Melaleuca Alternifolia) - 42.5 mg/g
Eucalyptus Oil (Eucalyptus radiata ) - 38.6 mg/g

Winter Green  Oil (Methyl Salicylate)- 50 mg/g

Purpose

OTC - PURPOSE SECTION

Pain relief cream to assist with relief of joint and muscle pain

Indication and Usage

INDICATIONS & USAGE SECTION

For the temporary relief of muscle andjoint aches and pains, includingsymptomatic relief of lower back pains.

May also assist with increased jointmobility & reduce inflammation andswelling of affected areas.

Contains phenoxyethanol as a preservative.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Apply a small amount of Muscle and Joint Heat Cream to the affected area and massage in until fully absorbed. Use twice

daily or more frequently if required.

Warnings

WARNINGS SECTION

For external use only.

Ensure safety seal is intact beforeopening. Keep tube sealed when not being used. Store below 300 C (86 F).

Keep out of reach from Children

Product Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

heat-creamheat-cream

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69594-003-012020-01-31C16284748780-19d75b9d0-1f2a-f424-e053-dadaa90a57ceMuscle and Joint Heat Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69594-003-01Muscle and Joint Heat Cream100 g in 1 TUBECREAM1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69594-003MUSCLE AND JOINT HEAT CREAM (EUCALYPTUS OIL AND TEA TREE OIL) CREAM [ULTRA MIX (AUST) PTY LTD ]3Legacy NDC, 1 package rows20160423_0a452a0b-6dea-4a03-b7ea-fec440f83c29.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
EUCALYPTUS OILACTIVE INGREDIENT2R04ONI6621
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
TEA TREE OILACTIVE INGREDIENTVIF565UC2G1
EUCALYPTUS OILACTIVE MOIETY2R04ONI6621
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
TEA TREE OILACTIVE MOIETYVIF565UC2G1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1

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
69594-00369594-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML · Source PDF

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 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a426dd55-6c88-40c1-87cb-e98c9cc3cc530a452a0b-6dea-4a03-b7ea-fec440f83c292016-04-08WarningsExact identifier
spl id: a426dd55-6c88-40c1-87cb-e98c9cc3cc53
spl set id: 0a452a0b-6dea-4a03-b7ea-fec440f83c29

Reported adverse events (FAERS/openFDA)#

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