Blue-emu Maximum Pain Relief Cream
FDA Label NDC 69993-300

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kingsway Pharmaceuticals Dba Nfi, Llc for the product Blue-emu Maximum Pain Relief (NDC 69993-300). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, allergy alert, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

DISTRIBUTED BY:
NFI CONSUMER PRODUCTS
501 Fifth Street • Bristol, TN 37620

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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, dimethicone, disodium EDTA, emu oil, ethylhexylglycerin, FD & C Blue#1, glucosamine, glycerin, glyceryl stearate and peg-100 stearate, methylsulfonylmethane, mineral oil, panthenol phenoxyethanol, polysorbate 80, stearic acid, triethanolamine, tocopherol acetate (Vitamin E ), water.

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)

Principal Display Panel (88 g Tube Label)

Principal Display Panel (88 g Tube Label)

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