OMEGA 3- capsaicin cream 
Concept Laboratories, Inc.

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 Cream

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

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

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 Leaf Extract, 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

Also contains
MSM, Glucosamine
& Capsaicin

8 FL OZ (237mL)

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
OMEGA 3 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-354
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (Capsaicin - UNII:S07O44R1ZM) Capsaicin2.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
LAURYL LAURATE (UNII: GPW77G0937)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ALFALFA (UNII: DJO934BRBD)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
ROSEMARY (UNII: IJ67X351P9)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
GINKGO (UNII: 19FUJ2C58T)  
FLAX SEED (UNII: 4110YT348C)  
CELOSIA ARGENTEA SEED (UNII: O1H314U8M2)  
ACAI (UNII: 46AM2VJ0AW)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EMU OIL (UNII: 344821WD61)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Hexylene Glycol (UNII: KEH0A3F75J)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETEARETH-12 (UNII: 7V4MR24V5P)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-354-18238 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34807/08/2016
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-354)

Revised: 9/2016
Document Id: f03f6245-da64-42ce-bc38-8cc774990b6a
Set id: 4d5c8d59-a968-4d96-a4a0-04b34ed08596
Version: 1
Effective Time: 20160915
 
Concept Laboratories, Inc.