BIO-MEGA

Dosage form: cream
Ingredients: MENTHOL 28.44g in 237mL, CAMPHOR (SYNTHETIC) 14.22g in 237mL
Labeler: Concept Laboratories, Inc.
NDC code: 64058-244

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

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 a thin layer 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 1-877-630-9788 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:

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

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 (MENTHOL)	MENTHOL	28.44 g in 237 mL
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC))	CAMPHOR (SYNTHETIC)	14.22 g in 237 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description
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	Operations
Concept Laboratories, Inc.		962282612	MANUFACTURE(64058-244)

Revised: 08/2014

Document Id: 65ff180a-b56f-4729-a5ca-c40dbda8b53a

Set id: 053c2bbb-16d1-44b3-b4dc-7f983903844f

Version: 2

Effective Time: 20140820

Concept Laboratories, Inc.

Further information

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

Medical Disclaimer