FDA.reportPublic FDA data

Blue-Emu Ultra with Hemp Seed

Manufacturer
Kingsway Pharmaceuticals dba NFI, LLC | Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:49:08

Label at a glance#

ProductBlue-Emu Ultra with Hemp Seed
Active ingredientTROLAMINE SALICYLATE
Label structure9 sections

Indications and uses

temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises • cramps

Dosage and administration

adults and children over 12 years of age: • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 4 times daily children 12 years or younger: ask a doctor.

Storage and handling

Store at 68-77°F (20-25°C)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Trolamine salicylate 10%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only

SPL UNCLASSIFIED SECTION

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged skin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years of age:

  • apply generously to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

children 12 years or younger: ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/c10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice (aloe vera), cannabis sativa seed oil, cetyl alcohol, dimethicone, disodium EDTA, emu oil, ethylhexylglycerin, FD & C Blue#1, glucosamine HCl, glycerin, glyceryl stearate and peg-100 stearate, methylsulfonylmethane, mineral oil, panthenol, phenoxyethanol, polysorbate 80, stearic acid, triethanolamine, tocopheryl acetate (Vitamin E), water.

SPL UNCLASSIFIED SECTION

 
DISTRIBUTED BY: NFI CONSUMER PRODUCTS
501 Fifth Street • Bristol, TN 37620 • 1-800-432-9334

PRINCIPAL DISPLAY PANEL – Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PAIN RELIEF
ULTRA
 

BLUE-EMU®
-HEMP-

CANNABIS SATIVA
SEED OIL + EMU OIL
 

TOPICAL PAIN RELIEF CREAM
NET WT 3 OZ. (88g)

image-01
image-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69993-200-03Blue-Emu Ultra with Hemp Seed88 g in 1 TUBECREAM883
69993-200-03Blue-Emu Ultra with Hemp Seed1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69993-200BLUE-EMU ULTRA WITH HEMP SEED (TROLAMINE SALICYLATE) CREAM [KINGSWAY PHARMACEUTICALS DBA NFI, LLC]3Current NDC, Legacy NDC, 2 package rows20241228_80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69993-20069993-200-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
TROLAMINE SALICYLATEH8O4040BHDACTIB
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
EMU OIL344821WD61IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
MINERAL OILT5L8T28FGPIACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
WATER059QF0KO0RIACT

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
Blue-Emu Ultra with Hemp SeedTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLC80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa92024-12-20WarningsExact identifier
ndc (package): 69993-200-03
ndc (product): 69993-200
ndc11 (package): 69993020003
spl id: 922d9d69-a52f-45bb-a8a6-50c1f0d170cc
spl set id: 80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9

Reported adverse events (FAERS/openFDA)#

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