BIOMEGA- 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.

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BioMega™

Drug Facts

Active ingredient

Capsicum Oleoresin 0.0625%

(Containing Capsaicin 0.025%)

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only.

  • This is not a face cream. Do not apply to the face.
  • Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.
  • Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
  • Do not bandage tightly.
  • Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and burning sensation.
  • Do not use with heating pad, hot water bottle or other source of heat Doing so can increase risk of serious burns.

When using this product

  • Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.

Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported.

If pregnant, breast-feeding or any medical conditions exist ask a health professional before use.

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult get medical attention immediately.

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 toll-free 1-877-630-9788 or visit us at www.biomegard.com

Manufactured for SCI Plano, TX 75024

Manufactured by: Concept Laboratories, Inc. Chicago, IL 60642

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

BIOMEGA™

Penetrating
HEAT PAIN THERAPY Cream

with Heating Capsaicin

Paraben-free topical analgesic for

Arthritis • Joint Pain • Muscle Ache • Cramps

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
BIOMEGA 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-355
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:64058-355-18238 g in 1 BOTTLE; Type 0: Not a Combination Product08/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/31/2016
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-355)

Revised: 9/2016
Document Id: dcbfe18e-004d-460c-aa24-e52f73d4f1c7
Set id: ca938e5d-8c61-4085-9271-aba13e9395b4
Version: 1
Effective Time: 20160921
 
Concept Laboratories, Inc.