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BIO-MEGA Heat Therapy

Dosage form: cream
Ingredients: Capsaicin 0.05925g in 237mL
Labeler: Concept Laboratories, Inc.
NDC code: 64058-245

BIO-MEGA
Heat Therapy

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

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

Flammable

Keep from Heat and Flame

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

Test on a small area for skin sensitivity prior to use. Wait 24 hours, if no reaction proceed. 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.

  • 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

Inactive ingredients

Water (Aqua), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Acrylates Copolymer, Linum Usitatissmum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Methane Carboximide, Methyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

Questions or comments?

Call toll-free 1-877-630-9788 or www.biomegarxp.com

Manufactured by: Concept Laboratories, Inc.
Chicago, IL 60642
#1651992

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

NDC 64058-245-68

BIO-MEGA
RXP

Penetrating
Heat
Therapy
Cream

with:

  • Heating
    Capsaicin
  • Omegas 3, 6 & 9
  • With Natural
    Ingredients
  • Six Hour
    Timed-Release
    Ice Pearls

8 FL OZ (237mL)

Paraben-free topical analgesic for:
Arthritis • Joint Pain • Muscle Ache • Cramps

BIO-MEGA   HEAT THERAPY
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-245
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (Capsaicin) Capsaicin0.05925 g  in 237 mL
Inactive Ingredients
Ingredient NameStrength
Water 
ARNICA MONTANA FLOWER 
METHYL DIISOPROPYL PROPIONAMIDE 
LAURYL LAURATE 
PHENOXYETHANOL 
DMDM HYDANTOIN 
IODOPROPYNYL BUTYLCARBAMATE 
ALOE VERA LEAF 
METHYL LACTATE, L- 
STARCH, CORN 
PPG-2 HYDROXYETHYL COCAMIDE 
TROLAMINE 
ALCOHOL 
PEPPERMINT OIL 
LINSEED OIL 
ACAI OIL 
ROSEMARY OIL 
Packaging
#Item CodePackage Description
1NDC:64058-245-68237 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/13/2014
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIOperations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-245)

Revised: 08/2014
 
Concept Laboratories, Inc.

Further information

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