Blue-Emu Maximum Arthritis Pain Relief Cream: Package Insert and Label Information

BLUE-EMU MAXIMUM ARTHRITIS PAIN RELIEF CREAM- trolamine salicylate cream
NFI Consumer Products

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.

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 mucos 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

Inactive Ingredients

acrylates/c10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice(Aloe Vera), cetyl alcohol, d-glucosamine, dimethicone, disodium EDTA, d- panthenol, emu oil, ethylhexylglycerin, F D & C Blue#1, glycerin, glyceryl stearate and peg-100 stearate, methylsulfonylmethane, mineral oil, phenoxyethanol, polysorbate 80, stearic acid, triethanolamine, tocopherol acetate(Vitamin E ), water.

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BLUE-EMU MAXIMUM ARTHRITIS PAIN RELIEF CREAM
trolamine salicylate 10% cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69993-250
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TROLAMINE SALICYLATE (SALICYLIC ACID) TROLAMINE SALICYLATE 100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN
DISODIUM EDTA-COPPER
ETHYLHEXYLGLYCERIN
GLYCERIN
POLYETHYLENE GLYCOL 4500
MINERAL OIL
STEARIC ACID
TROLAMINE
WATER
ALOE VERA LEAF
CETYL ALCOHOL
GLUCOSAMINE
DIMETHICONE
CARBOMER COPOLYMER TYPE A
FD&C BLUE NO. 1
PANTHENOL
EMU OIL
GLYCERYL MONOSTEARATE
DIMETHYL SULFONE
PHENOXYETHANOL
ALPHA-TOCOPHEROL ACETATE
Product Characteristics
Color blue Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69993-250-03 88 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 06/01/2015
Labeler — NFI Consumer Products (016785052)
Establishment
Name Address ID/FEI Operations
UPM Pharmaceuticals 032125469 manufacture (69993-250)

Revised: 10/2017 NFI Consumer Products

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