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Drug Facts
Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.
Blue-emu Ultra With Hemp Seed Cream
FDA Label NDC 69993-200
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 Ultra With Hemp Seed (NDC 69993-200). 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, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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.
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
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, tocopherol acetate(Vitamin E), water.
Principal Display Panel - 88 G Tube Carton
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)
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