FDA.reportPublic FDA data

Broadway Joe's Pain Cream - 2 oz

Manufacturer
USA Hemp Store LLC | Lexia LLC
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:44:22

Label at a glance#

Producthistamine dihydrochloride
Active ingredientHISTAMINE DIHYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

Broadway Joe's Pain Cream

OTC - ACTIVE INGREDIENT SECTION

Histamine dihydrochloride

Braodway Joe's Pain Cream

INACTIVE INGREDIENT SECTION

Water, Glyceryl Stearate, Caprylic/Capric, Triglyceride, Cetyl Alcohol, Butylene Glycol, Cannabidiol, Cetearyl 2- thylhexanoate, Sodium Hyaluronate, Glycerin, Tapioca Starch, Polymethylsilsesquioxane, Stearic Acid, Cannabis Sativa (Hemp) Seed Oil, 3-glyceryl Ascorbate (Vitamin C), Isonononyl Isononanoate, Tocopheryl Acetate (Vitamin E), Dimethicone, Polysorbate 80, Carbomer, Sodium Hydroxide, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol

Broadway Joe's Pain Cream

DOSAGE & ADMINISTRATION SECTION

  • For use by adults and children over 13 yrs old.
  • Gently massage the product on to clean dry skin as needed.
  • For topical use only, do not ingest.
  • Provides temporary relief from aches and pains associated with simple backaches,strains, sprains, arthritis, bruises.
  • Apply a thin layer to pain site and massage until thoroughly absorbed into skin.

Broadway Joe's Pain Cream

INDICATIONS & USAGE SECTION

Topical Analgesic

Broadway Joe's Pain Cream

SPL UNCLASSIFIED SECTION

Store between 40 degrees F and 86 degrees F (4 degrees C and 30 degrees C).

Broadway Joe's Pain Cream

WARNINGS SECTION

Warnings · For external use only.
Do not use on open wounds or damaged skin or with a heating pad.


When using this product · avoid contact with eyes or mucous membranes. If product contacts your eyes, rinse thoroughly with water. Do not bandage tightly. · Do not use with other ointments, creams, or sprays.


Stop use and ask a doctor if you experience redness or excessive skin irritation over the affected area. · If the condition worsens, or symptoms persist for more than 7 days please consult a Dr.


Keep out of reach of children. If swallowed, seek medical help, or contact a Poison Control Center immediately.


If pregnant or breast feeding, ask a health professional before use.

Broadway Joe's Pain Cream

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience redness or excessive skin irritation over the affected area. · If the condition worsens,
or symptoms persist for more than 7 days, please consult a Dr.

Broadway Joe's Pain Cream

OTC - PURPOSE SECTION

Topical Analgesic

Broadway Joe's - 2oz

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, seek medical help or contact a poison control center immediately.

Broadway Joe's Pain Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Side - Drug FactsSide - Drug FactsSide LabelSide LabelTop LabelTop Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83088-8120-52025-08-01C16284748780-13b156c62-26fd-fb37-e063-e6dba90a4e07Broadway Joe's Pain Cream - 2 oz
83088-8120-52025-07-29C16284748780-13b156c62-26fd-fb37-e063-e6dba90a4e07Broadway Joe's Pain Cream - 2 oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83088-8120-5histamine dihydrochloride59 mL in 1 JARCREAM593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83088-8120HISTAMINE DIHYDROCHLORIDE CREAM [USA HEMP STORE LLC]31 package rows20241219_f06e6ff6-2af4-06d0-e053-2995a90a88f6.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83088-812083088-8120-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISONONYL ISONONANOATES4V5BS6GCXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CETYL ALCOHOL936JST6JCNIACT
STEARIC ACID4ELV7Z65APIACT
DIMETHICONE 3502Y53S6ATLUIACT
POLYSORBATE 806OZP39ZG8HIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
CANNABIDIOL19GBJ60SN5IACT
HEXYLENE GLYCOLKEH0A3F75JIACT
HYALURONIC ACIDS270N0TRQYIACT
3-GLYCERYL ASCORBATE3R1Q5X5GGOIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CAPRYLIC/CAPRIC ACIDDI775RT244IACT
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMEREPA1872R1NIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL DICAPRATE3Z317CA098IACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
TOCOPHERYL RETINOATE0WN694NBMMIACT
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
CETEARYL OLIVATE58B69Q84JOIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
297bad8c-49da-94b8-e063-6394a90af6aff06e6ff6-2af4-06d0-e053-2995a90a88f62024-12-17WarningsExact identifier
spl id: 297bad8c-49da-94b8-e063-6394a90af6af
spl set id: f06e6ff6-2af4-06d0-e053-2995a90a88f6

Reported adverse events (FAERS/openFDA)#

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