FDA.reportPublic FDA data

Westside Pain Specialists (as PLD) - Pain Cream (83501-101)

Manufacturer
Newbury Extracts, LLC
Effective date
2024-09-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:22:20

Label at a glance#

ProductNEWBURY BLUE PAIN BALM
Active ingredientMETHYL SALICYLATE, CAMPHOR (SYNTHETIC), MENTHOL
Label structure10 sections

Indications and uses

FOR RELIEF FROM ACHES, ARTHRITIS, MUSCLE SPASMS, AND OVERALL NECK AND BACK PAIN.

Dosage and administration

APPLY BALM LIBERALLY AND GENTLY MASSAGE THE AFFECTED AREA. MASSAGE UNTIL ABSORBED INTO SKIN. WASH HANDS WITH WATER AND SOAP AFTER APPLICATION AND AVOID CONTACT WITH EYES. CHILDREN UNDER 18 YEARS OF AGE SHOULD CONSULT A PHYSICIAN BEFORE USE.

Storage and handling

STORE BETWEEN 15-30°C (59-86°F). AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F).

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Camphor 3%

Menthol 10%

Methyl Salicylate 25%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANESTHETIC

USES

INDICATIONS & USAGE SECTION

FOR RELIEF FROM ACHES, ARTHRITIS, MUSCLE SPASMS, AND OVERALL NECK AND BACK PAIN.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY. WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

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.

STOP USE AND ASK A DOCTOR IF:

OTC - STOP USE SECTION

  • AN ALLERGIC REACTION OCCURS
  • REDNESS, IRRITATION, SWELLING, PAIN OR OTHER SYMPTOMS BEGIN.
  • THE CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS

OTHER INFORMATION

STORAGE AND HANDLING SECTION

STORE BETWEEN 15-30°C (59-86°F). AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40°C (104°F).

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

APPLY BALM LIBERALLY AND GENTLY MASSAGE THE AFFECTED AREA. MASSAGE UNTIL ABSORBED INTO SKIN. WASH HANDS WITH WATER AND SOAP AFTER APPLICATION AND AVOID CONTACT WITH EYES. CHILDREN UNDER 18 YEARS OF AGE SHOULD CONSULT A PHYSICIAN BEFORE USE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ALOE BARBADENSIS FLOWER EXTRACT, AMPELOPSIS JAPONICA ROOT EXTRACT, ANGELICA POLYMORPHA SINENSIS ROOT EXTRACT, ANGELICA PUBESCENS ROOT EXTRACT, BEESWAX (CERA ALBA), BOSWELLIA CARTERII RESIN EXTRACT, CAMPHOR, CANOLA OIL, CINNAMOMUM CASSIA BARK EXTRACT, COCCINIA INDICA (IVY GOURD) FRUIT EXTRACT, CORALLINA OFFICINALIS (SEAWEED) EXTRACT, CURCUMA LONGA ROOT EXTRACT, EUCALYPTUS GLOBULUS LEAF OIL, EUPHORBIA CERIFERA (CANDELILLA WAX) CERA, GLYCYRRHIZA URALENSIS ROOT EXTRACT, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, MELIA AZADIRACHTA FLOWER EXTRACT, MELIA AZADIRACHTA LEAF EXTRACT, MENTHA PIPERITA (PEPPERMINT) OIL, MENTHOL, METHYL SALICYLATE, OCIMUM BASILICUM (BASIL) FLOWER/LEAF EXTRACT, OCIMUM SANCTUM (TULSI) LEAF EXTRACT, OLYHYDROXYSTEARIC ACID, REHMANNIA GLUTINOSA ROOT EXTRACT, RICINUS COMMUNIS (CASTOR) SEED OIL, SCROPHULARIA NODOSA EXTRACT, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, SOLANUM MELONGENA (EGGPLANT) FRUIT EXTRACT, TOCOPHERYL ACETATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

UCUC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2689786camphor 3 % / menthol 10 % / methyl salicylate 25 % Topical OintmentPSN4
2689786camphor 0.03 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.25 MG/MG Topical OintmentSCD4
2689786camphor 3 % / menthol 10 % / methyl salicylate 25 % Topical OintmentSY4

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83501-101-11NEWBURY BLUE PAIN BALM30 mL in 1 JAROINTMENT304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83501-101NEWBURY BLUE PAIN BALM (CAMPHOR, MENTHOL, METHYL SALICYLATE) OINTMENT [NEWBURY EXTRACTS, LLC]41 package rows20241003_1ecf6372-b3db-45af-e063-6294a90ac768.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83501-10183501-101-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
CINNAMOMUM CASSIA WHOLE9BPF21T8ZRIACT
CANOLA OIL331KBJ17RKIACT
CORALLINA OFFICINALIS4004498D06IACT
AZADIRACHTA INDICA LEAFHKY915780TIACT
SOLANUM MELONGENA WHOLE5DS5EE0N93IACT
OCIMUM BASILICUM WHOLEP4815JL4O3IACT
HOLY BASIL LEAFSCJ765569PIACT
FRANKINCENSER9XLF1R1WMIACT
COCCINIA GRANDIS WHOLES4R7X48WEDIACT
CANDELILLA WAXWL0328HX19IACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
SCROPHULARIA NODOSA7H443NUB2TIACT
ALOE VERA LEAFZY81Z83H0XIACT
ANGELICA PUBESCENS ROOT0MF1EI01KJIACT
AMPELOPSIS JAPONICA ROOTO2672197TFIACT
ANGELICA POLYMORPHA ROOTHZ12173363IACT
CURCUMA LONGA WHOLEW5488JUO8UIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
AZADIRACHTA INDICA FLOWER3TE8A92UPMIACT
PEPPERMINT OILAV092KU4JHIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
JOJOBA OIL724GKU717MIACT
GLYCYRRHIZA URALENSIS ROOT42B5YD8F0KIACT
CASTOR OILD5340Y2I9GIACT
REHMANNIA GLUTINOSA ROOT1BEM3U6LQQIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
METHYL SALICYLATELAV5U5022YACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB

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
235d83ca-e3dd-3493-e063-6394a90aa4f91ecf6372-b3db-45af-e063-6294a90ac7682024-09-30WarningsExact identifier
spl id: 235d83ca-e3dd-3493-e063-6394a90aa4f9
spl set id: 1ecf6372-b3db-45af-e063-6294a90ac768

Reported adverse events (FAERS/openFDA)#

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