BIO-MEGA- menthol and camphor (synthetic) 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

Drug Facts

Active ingredientPurpose
Menthol 12%Pain Relieving
Camphor 6%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

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Flammable

Keep from heat and flame.

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

  • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
  • 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), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, 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, 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

Triple Strength
Pain
Relief
Cream

with:

  • Cooling Menthol
    & Camphor
  • Omegas 3, 6 & 9
  • With Natural
    Ingredients
  • Six Hour
    Timed-Release

Ice Pearls ™

8 FL OZ (237mL)

Paraben-free topical analgesic for:
Strains • Sprains • Muscle Pain • Tension

Principal Display Panel - 237 mL Bottle Label
BIO-MEGA 
menthol and camphor (synthetic) cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:64058-244
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL28.44 g  in 237 mL
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)14.22 g  in 237 mL
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 
METHYL LACTATE, L- 
LAURYL LAURATE 
DMDM HYDANTOIN 
PHENOXYETHANOL 
IODOPROPYNYL BUTYLCARBAMATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-244-68237 mL in 1 BOTTLE
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(64058-244)

Revised: 2/2014
Document Id: e07c0db7-34d1-4f52-9f8c-0958ace00ebf
Set id: 053c2bbb-16d1-44b3-b4dc-7f983903844f
Version: 1
Effective Time: 20140218
 
Concept Laboratories, Inc.