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BioMega Cold Pain Therapy

Medically reviewed on Feb 5, 2018

Dosage form: cream
Ingredients: MENTHOL, UNSPECIFIED FORM 0.12g in 1g, CAMPHOR (SYNTHETIC) 0.06g in 1g
Labeler: Concept Laboratories, Inc.
NDC Code: 64058-344

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.

BioMega™
Cold Pain Therapy Cream

Drug Facts

Active ingredientPurpose
Menthol 12% Topical Analgesic
Camphor 6%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.
  • If sensitive skin, ask a health professional before use. Do not use if past allergic reaction to menthol or camphor.
  • 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, burning sensation or cold 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, skin irritation or blistering of the skin.

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. Get emergency medical help if difficulty breathing, swelling of face, lips, tongue or throat, or hives.

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.

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, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, 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.

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™

Triple Strength

COLD PAIN THERAPY Cream

with Cooling Menthol &
Camphor

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

8 FL OZ (237mL)

BIOMEGA   COLD PAIN THERAPY
menthol, unspecified form and camphor (synthetic) cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-344
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL, UNSPECIFIED FORM) MENTHOL, UNSPECIFIED FORM0.12 g  in 1 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALOE VERA LEAF 
PROPYLENE GLYCOL 
PEPPERMINT OIL 
ALCOHOL 
STARCH, CORN 
ARNICA MONTANA FLOWER 
LINSEED OIL 
ROSEMARY OIL 
ACAI OIL 
PPG-2 HYDROXYETHYL COCAMIDE 
METHYL DIISOPROPYL PROPIONAMIDE 
ETHYL MENTHANE CARBOXAMIDE 
MENTHYL LACTATE, (-)- 
LAURYL LAURATE 
Packaging
#Item CodePackage Description
1NDC:64058-344-68234 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34801/07/2016
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIOperations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-344)

 
Concept Laboratories, Inc.

Further information

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

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