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Blue-Emu Maximum Pain Relief

Blue-Emu Maximum Pain Relief Cream

Approved
Approval ID

c863351a-951b-4f7c-a9c0-4289d702054a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 9, 2025

Manufacturers
FDA

Kingsway Pharmaceuticals dba NFI, LLC

DUNS: 121681919

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

TROLAMINE SALICYLATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69993-300
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
TROLAMINE SALICYLATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 9, 2025
FDA Product Classification

INGREDIENTS (22)

TROLAMINE SALICYLATEActive
Quantity: 0.1 g in 1 g
Code: H8O4040BHD
Classification: ACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)Inactive
Code: 59TL3WG5CO
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
DIMETHICONE, UNSPECIFIEDInactive
Code: 92RU3N3Y1O
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
EMU OILInactive
Code: 344821WD61
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GLUCOSAMINE HYDROCHLORIDEInactive
Code: 750W5330FY
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCERYL STEARATE/PEG-100 STEARATEInactive
Code: RD25J5V947
Classification: IACT
DIMETHYL SULFONEInactive
Code: 9H4PO4Z4FT
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 12/20/2024

PRINCIPAL DISPLAY PANEL - 88 g Tube Label

ARTHRITIS | MUSCLES | JOINTS

BLUE-EMU**®**

Fast Acting
Odor Free
+ Emu Oil

Maximum
Pain Relief

AMERICA'S
#1
EMU OIL FORMULA
ODOR
FREE

Contains Emu Oil
NET WT 3 OZ. (88g)

tube-01

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 12/20/2024

Uses

Temporarily relief of minor aches and pains of muscles and joints associated with:

Arthritis

Simple backache

strains

sprains

bruises

WARNINGS AND PRECAUTIONS SECTION

LOINC: 43685-7Updated: 12/20/2024

Ca Consumer Warning:

This product can expose you to trace levels of diethanolamine (DEA), which is know to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 12/20/2024

Active Ingredients

Trolamine Salicylate 10%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 12/20/2024

Purpose

Topical Analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 4/25/2023

Warnings

For external use only

Allergy alert:

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

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

do not apply to wounds or damaged skin.

Stop use and ask a doctor if

condition worsens

symptoms persist for more than 7 days or clear up and occur again within a few days

redness is present

irritation develops.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/25/2023

Directions

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.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 12/20/2024

Inactive Ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice (aloe vera), 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, tocopheryl acetate (Vitamin E), triethanolamine, water.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 4/25/2023

DISTRIBUTED BY:
NFI CONSUMER PRODUCTS
501 Fifth Street • Bristol, TN 37620
TOLL FREE: 1-800-432-9334
WWW.BLUE-EMU.COM

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Blue-Emu Maximum Pain Relief - FDA Drug Approval Details