FDA.reportPublic FDA data

Outback Pain Relief Liquid Cream

Manufacturer
Derma Care Research Labs, LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:47:50

Label at a glance#

ProductOutback Pain Relief
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Camphor 6%, Menthol 16%

OTC - PURPOSE SECTION


Topical Analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.

WARNINGS SECTION

For external use only. When using this product use only as directed, do not bandage tightly or use with a heating pad, avoid contact with eyes or mucous membranes, and do not apply to wounds or damaged skin. Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a health professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older apply generously to the affected area not more than 4 times daily. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Glycerin, Laureth-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polyacrylamide, Sorbitan Olivate, Tocopherol, Vanilla Planifolia Fruit Extract, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2542732camphor 6 % / menthol 16 % Topical CreamPSN3
2542732camphor 60 MG/ML / menthol 160 MG/ML Topical CreamSCD3
2542732camphor 6 % / menthol 16 % Topical CreamSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-987-02Outback Pain Relief57 g in 1 TUBECREAM573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-987OUTBACK PAIN RELIEF (CAMPHOR 6%, MENTHOL 16%) CREAM [DERMA CARE RESEARCH LABS, LLC]3Current NDC, Legacy NDC, 1 package rows20241222_c238c930-2012-2d48-e053-2a95a90a8a4a.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72839-98772839-987-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
WATER059QF0KO0RIACT
CETYL ALCOHOL936JST6JCNIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
TEA TREE OILVIF565UC2GIACT
TOCOPHEROLR0ZB2556P8IACT
VANILLA BEANQ74T35078HIACT
CETEARYL OLIVATE58B69Q84JOIACT
SORBITAN OLIVATEMDL271E3GRIACT
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)5F4963KLHSIACT
BENZYL ALCOHOLLKG8494WBHIACT
C13-14 ISOPARAFFINE4F12ROE70IACT

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
Outback Pain ReliefCAMPHOR 6%, MENTHOL 16%Derma Care Research Labs, LLCc238c930-2012-2d48-e053-2a95a90a8a4a2024-12-20WarningsExact identifier
ndc (package): 72839-987-02
ndc (product): 72839-987
ndc11 (package): 72839098702
spl id: 29b762dd-130b-def5-e063-6394a90a2b50
spl set id: c238c930-2012-2d48-e053-2a95a90a8a4a

Reported adverse events (FAERS/openFDA)#

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