FDA.reportPublic FDA data

XCEPTOR PAIN CREAM

Manufacturer
XCEPTOR LLC
Effective date
2020-07-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:21:36

Label at a glance#

ProductXCEPTOR PAIN
Active ingredientMETHYL SALICYLATE
Label structure10 sections

Indications and uses

TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS.

Dosage and administration

ADULTS AND CHILDREN 12 YRS AND OLDER APPLY A BEAD OF PRODUCT OVER AFFECTED AREA, RUB IN. SAFE TO ADD MORE FOR ADDITIONAL RELIEF. CHILDREN UNDER 12 CONSULT A PHYSICIAN.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

METHYL SALICYLATE  10%

PURPOSE

OTC - PURPOSE SECTION

TOPICAL ANALGESIC

USES

INDICATIONS & USAGE SECTION

TOPICAL PAIN RELIEF FOR MINOR ACHES AND PAINS.

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

ALLERGY ALERT: IF ALLERGIC TO ASPERIN OR SALICYLATES OR MENTHOL CONSULT A PHYSICIAN PRIOR TO USE.

DO NOT USE:

  • ON WOUNDS OR DAMAGED SKIN
  • WITH A HEATING PAD
  • ON A CHILD UNDER 12 WITH ARTHRITIS-LIKE CONDITIONS
  • ON INFLAMED SKIN
  • WITH OTHER TOPICAL PAIN RELIEF PRODUCTS

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES OR MUCOUS MEMBRANES, AVOID EXPOSURE TO SUNLIGHT.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

ADULTS AND CHILDREN 12 YRS AND OLDER APPLY A BEAD OF PRODUCT OVER AFFECTED AREA, RUB IN. SAFE TO ADD MORE FOR ADDITIONAL RELIEF. CHILDREN UNDER 12 CONSULT A PHYSICIAN.

OTHER INFORMATION

OTHER SAFETY INFORMATION

STORE AT 20° - 25°C (68°-77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, COCONUT ALKANES, COC-CAPRYLATE/CAPRATE, GLYCERINE, ALOE BARBADENSIS LEAF JUICE, CANNABIS SATIVA SEED OIL, DISTEARDIMONIUM HECTORITE, CAPRYLIC/CAPRIC TRIGLYCERIDES, SODIUM CHLORIDE, CYCLODEXTRIN, POLYGLYCERYL-3 POLYRICINOLEATE, POLYGLYCERYL-3 DIISOSTEARATE, BETAINE, CANNABIDOIL (FROM HEMP), COCOS NUCIFERA (COCONUT) OIL, HYALURONIC ACID, LECITHIN, LINOLEIC ACID, OLEIC ACID, PALMITIC ACID, PHENOXYETHANOL, PHYTOSTEARYL CANOLA GLYCERIDES, POTASSIUM SORBATE, SODIUM BENZOATE, SORBIC ACID, STEARIC ACID, TOCOPHEROL, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, XANTHAN GUM.

QUESTIONS / COMMENTS?

OTC - QUESTIONS SECTION

PLEASE CALL US AT (760) 710-0510

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Cream LBLPain Cream LBL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311635methyl salicylate 10 % Topical CreamPSN6
311635methyl salicylate 100 MG/ML Topical CreamSCD6
311635methyl salicylate 10 % Topical CreamSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72519-101-112022-01-28C16284748780-1d6a99b39-913f-a426-e053-dadaa90af4c2XCEPTOR PAIN CREAM
72519-101-212022-01-28C16284748780-1d6a99b39-913f-a426-e053-dadaa90af4c2XCEPTOR PAIN CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72519-101-11XCEPTOR PAIN90 mL in 1 TUBECREAM906
72519-101-21XCEPTOR PAIN30 mL in 1 BOTTLE, DISPENSINGCREAM306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72519-101XCEPTOR PAIN (MENTHOL) CREAM [XCEPTOR LLC]6Legacy NDC, 2 package rows20200716_d09dd40d-166b-4ce5-b22e-f6db17dce312.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
72519-10172519-101-11, 72519-101-21

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
METHYL SALICYLATELAV5U5022YACTIB
WATER059QF0KO0RIACT
COCONUT ALKANES1E5KJY107TIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SODIUM CHLORIDE451W47IQ8XIACT
BETADEXJV039JZZ3AIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
BETAINE3SCV180C9WIACT
CANNABIDIOL19GBJ60SN5IACT
COCONUT OILQ9L0O73W7LIACT
HYALURONIC ACIDS270N0TRQYIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
LINOLEIC ACID9KJL21T0QJIACT
OLEIC ACID2UMI9U37CPIACT
PALMITIC ACID2V16EO95H1IACT
PHENOXYETHANOLHIE492ZZ3TIACT
CANOLA OIL331KBJ17RKIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBIC ACIDX045WJ989BIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
TREMELLA FUCIFORMIS FRUITING BODYGG8N28393GIACT
XANTHAN GUMTTV12P4NEEIACT

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
58b3f755-b248-4e52-af3e-905175d70b94d09dd40d-166b-4ce5-b22e-f6db17dce3122020-07-15WarningsExact identifier
spl id: 58b3f755-b248-4e52-af3e-905175d70b94
spl set id: d09dd40d-166b-4ce5-b22e-f6db17dce312

Reported adverse events (FAERS/openFDA)#

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