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 ingredient Purpose
Menthol 12% Pain Relieving
Camphor 6% Pain Relieving

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

Warnings

For external use only.

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

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 1-877-630-9788 or
www.biomegarxp.com

Manufactured by: Concept Laboratories, Inc.
Chicago, IL 60642
#1651994

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

NDC 64058-244-68

BIO-MEGA
RXP

Triple Strength
Pain
Relief
Cream

with:

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 Type HUMAN OTC DRUG Item Code (Source) NDC:64058-244
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 28.44 g  in 237 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 14.22 g  in 237 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALCOHOL (UNII: 3K9958V90M)  
STARCH, CORN (UNII: O8232NY3SJ)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
LINSEED OIL (UNII: 84XB4DV00W)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
ACAI OIL (UNII: Z0W6766A2W)  
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
METHYL LACTATE, L- (UNII: 0379G9C44S)  
LAURYL LAURATE (UNII: GPW77G0937)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64058-244-68 237 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 01/13/2014
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
Name Address ID/FEI Business Operations
Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-244)

Revised: 8/2014
Document Id: 65ff180a-b56f-4729-a5ca-c40dbda8b53a
Set id: 053c2bbb-16d1-44b3-b4dc-7f983903844f
Version: 2
Effective Time: 20140820
 
Concept Laboratories, Inc.