BIO-MEGA  HEAT THERAPY- 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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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

  • Children under 12 years of age consult a physician
  • Apply liberally 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 1-888-373-8831

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

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

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

Principal Display Panel - 237 mL Bottle Label
BIO-MEGA   HEAT THERAPY
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-245)

Revised: 2/2014
Document Id: 1830a4ab-57bd-4b83-9848-aa987efa4fd6
Set id: 0c54a355-4abe-4cfd-bc15-29a36463929b
Version: 1
Effective Time: 20140221
 
Concept Laboratories, Inc.