BLUE-EMU PAIN RELIEF MICRO-FOAM- trolamine salicylate aerosol, foam

Blue-Emu Pain Relief Micro-Foam by

Drug Labeling and Warnings

Blue-Emu Pain Relief Micro-Foam by is a Otc medication manufactured, distributed, or labeled by NFI, LLC, Formulated Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 68-77oF (20-25oC)

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, nitrous oxide, panthenol, phenoxyethanol, polysorbate 80, stearic acid, triethanolamine, tocopherol acetate (Vitamin E), water.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL – Canister Label

SOFT & SOOTHING
 
BLUE-EMU®
 
Fast Acting
Odor Free
+ Emu Oil
 
Pain Relief
Micro-Foam™
 
AMERICA'S
# 1
ODOR
FREE
EMU OIL FORMULA
 
Contains Emu Oil
NET WT 3.5 OZ (99.2g)

INGREDIENTS AND APPEARANCE

BLUE-EMU PAIN RELIEF MICRO-FOAM 
trolamine salicylate aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69993-500
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ)	TROLAMINE SALICYLATE	0.1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
EMU OIL (UNII: 344821WD61)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLUCOSAMINE (UNII: N08U5BOQ1K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
MINERAL OIL (UNII: T5L8T28FGP)
NITROUS OXIDE (UNII: K50XQU1029)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69993-500-35	99.2 g in 1 CANISTER; Type 0: Not a Combination Product	04/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/05/2021

Labeler - Kingsway Pharmaceuticals dba NFI, LLC (121681919)

Registrant - Kingsway Pharmaceuticals dba NFI, LLC (121681919)

Establishment
Name	Address	ID/FEI	Business Operations
Formulated Solutions, LLC		143266687	MANUFACTURE(69993-500)