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Omega 3 by Concept Laboratories, Inc.

Medically reviewed on April 22, 2017

Dosage form: cream
Ingredients: Capsaicin 0.025ug in 1mL
Labeler: Concept Laboratories, Inc.
NDC Code: 64058-358

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.

Omega 3

Drug Facts

Active ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Purpose

Pain Relieving

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains
  • bruises

Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, pack, wrap, hot water bottle or any heating element

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
  • if pregnant or nursing, seek the advice of a health professional before using

Directions
  • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
  • Children under 12 years of age consult a physician
  • Apply a thin layer to affected area not more than 3 to 4 times daily
  • Gently massage into the skin until fully absorbed
  • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
  • A burning sensation may occur upon initial application but generally disappears with continued use. For a severe burning discomfort, remove excess product with a soft cloth and cooking oil.

Inactive ingredients

Water (Aqua), Butylene Glycol, Glycerin, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Medicago Sativa (Alfalfa) Extract, Arnica Montana Flower Extract, Cymbopogon Schoenanthus Stem/Leaf/Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Celosia Argentea Seed Extract, Euterpe Oleracea Fruit Extract, Mentha Piperita (Peppermint) Oil, Glucosamine HCl, Dimethyl Sulfone, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate, Cetearyl Isononanoate, Ceteareth-20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth-12, Cetyl Palmitate, Emu Oil, Polysorbate 20, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Sodium Hydroxide.

Questions or comments?

Call 1-888-373-8831

Manufactured by: Concept Laboratories, Inc. Chicago, IL 60642 (USA)

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

OMEGA
3

PAIN RELIEVING CREAM

Fast, Long-Lasting Relief
for Muscle & Joint Pain
with Omega-3 Fatty Acids

  • Powerful Anti-Inflammatory
  • Soothing Nutritive Abilities
  • Natural Antioxidant Protection
  • Safe Alternative to Pills

Also contains
MSM, Glucosamine
& Capsaicin

8 FL OZ (237mL)

OMEGA 3 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-358
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (Capsaicin) Capsaicin0.025 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
ALOE VERA LEAF 
METHYL DIISOPROPYL PROPIONAMIDE 
ETHYL MENTHANE CARBOXAMIDE 
MENTHYL LACTATE, (-)- 
LAURYL LAURATE 
STARCH, CORN 
HYDRATED SILICA 
GLUCOSAMINE HYDROCHLORIDE 
DIMETHYL SULFONE 
GLYCERIN 
SUNFLOWER OIL 
ALFALFA 
ARNICA MONTANA FLOWER 
CYMBOPOGON SCHOENANTHUS TOP 
ROSEMARY 
MENTHA PIPERITA LEAF 
ASIAN GINSENG 
GINKGO 
FLAX SEED 
CELOSIA ARGENTEA SEED 
ACAI 
EDETATE DISODIUM 
EMU OIL 
POLYSORBATE 20 
.ALPHA.-TOCOPHEROL ACETATE 
BUTYLENE GLYCOL 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
Ethylhexylglycerin 
Hexylene Glycol 
CETEARYL ISONONANOATE 
POLYOXYL 20 CETOSTEARYL ETHER 
CETOSTEARYL ALCOHOL 
GLYCERYL MONOSTEARATE 
CETEARETH-12 
CETYL PALMITATE 
SODIUM HYDROXIDE 
PEPPERMINT OIL 
Packaging
#Item CodePackage Description
1NDC:64058-358-18237 mL in 1 BOTTLE
2NDC:64058-358-1259 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34811/16/2016
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIOperations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-358)

 
Concept Laboratories, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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