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BioMega Heat Pain Therapy

Dosage form: cream
Ingredients: Capsaicin 0.25mg in 1g
Labeler: Concept Laboratories, Inc.
NDC code: 64058-247

BioMega™
Heat Pain Therapy

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

simple backache
arthritis
strains
sprains

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
Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock.
Before using on children under 18 years of age consult a physician.
Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small skin area to test for sensitivity or skin reaction.
Gently massage into the skin until fully absorbed.
Wash hands with soap and water thoroughly 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.

WARNING

FLAMMABLE PRODUCT!

Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

Inactive ingredients

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

Questions or comments?

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

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

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

BIOMEGA™

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

Penetrating

HEAT PAIN THERAPY Cream

with Heating Capsaicin

  • Omegas 3, 6 & 9
  • With Natural Ingredients
  • Ice Pearls™ Technology
    For Hours Of Therapy

8 FL OZ (237mL)

BIOMEGA   HEAT PAIN THERAPY
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-247
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (Capsaicin) Capsaicin0.25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
ARNICA MONTANA FLOWER 
METHYL DIISOPROPYL PROPIONAMIDE 
LAURYL LAURATE 
ALOE VERA LEAF 
MENTHYL LACTATE, (-)- 
STARCH, CORN 
PPG-2 HYDROXYETHYL COCAMIDE 
TROLAMINE 
ALCOHOL 
PEPPERMINT OIL 
LINSEED OIL 
ACAI OIL 
ETHYL MENTHANE CARBOXAMIDE 
HYDRATED SILICA 
ROSEMARY OIL 
Packaging
#Item CodePackage Description
1NDC:64058-247-68234 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34802/04/2016
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIOperations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-247)

Revised: 02/2016
 
Concept Laboratories, Inc.

Further information

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