BLUE-EMU ULTRA WITH HEMP SEED- trolamine salicylate cream 
NFI, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Blue-Emu® Ultra with Hemp Seed Oil

Active ingredient

Trolamine salicylate 10%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

arthritis
simple backache
muscle strains
sprains
bruises
cramps

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.

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.

Other information

Store at 68-77°F (20-25°C)

Inactive ingredients

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.

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

PRINCIPAL DISPLAY PANEL - 88 g Tube Carton Label

ULTRA

BLUE-EMU®
-HEMP-

CANNABIS SATIVA
SEED OIL + EMU OIL

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

PRINCIPAL DISPLAY PANEL - 88 g Tube Carton
BLUE-EMU ULTRA WITH HEMP SEED 
trolamine salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69993-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE0.1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN (UNII: 344S277G0Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
EMU OIL (UNII: 344821WD61)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
MINERAL OIL (UNII: T5L8T28FGP)  
PANTHENOL (UNII: WV9CM0O67Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69993-200-031 in 1 CARTON04/05/2021
188 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/05/2021
Labeler - NFI, LLC (121681919)
Establishment
NameAddressID/FEIBusiness Operations
Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals081301372MANUFACTURE(69993-200)

Revised: 4/2023
Document Id: 450129ab-f868-4f4f-ab27-258d8b35940d
Set id: 80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9
Version: 2
Effective Time: 20230425
 
NFI, LLC