BIOFREEZE  - menthol spray 
Performance Health Inc.

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Biofreeze Pain Relieving Spray

Drug Facts

Active Ingredients                                       Purpose

Natural Menthol USP 10%    .................     Cooling Pain Reliever

Purpose
  Cooling Pain Reliever

Uses: Temporary relief from minor aches and pains of

sore muscles and joints associated with : -arthritis - backache

strains - sprains

Warnings: For external use only

Flammable: Keep away from excessive heat or open flame

Ask a doctor before use if you have: sensitive skin

When Using This Produce: -Avoid contact with the eyes or

mucous membranes - Do not apply to wounds or damages skin

-Do not use with other ointments, creams, sprays or liniments

-Do not apply to irritated  skin or if excessive irritation develops

-Do not bandage - Wash hands after use with cool water

-Do not use with heating pad or device

Stop Use And Ask A Doctor If: Condition worsens, or if

symptoms persist for more than 7 days, or clear up and reoccur


If pregnant or breastfeeding: Ask a health professional before use.

Keep out of reach of children: If accidentally ingested, get

medical help or contact a Poison Control Center immediately.

Directions - Adults and children 12 years of age and older:
Spray on to the affected areas not more than 4 times daily; massage
not necessary.

-Children under 12 years of age: Consult physician

Other Information :  Store in a cool dry place with lid closed tightly

Arnica Montana, Calendula,

Chamomile, Dimethyl Sulfone, Echinacea,

Ethanol , ILEX Paraguarenis,

Isopropyl Myristate, Juniper Berry, Water, White Tea

Questions or Comments? 1-800-246-3733

BIOFREEZE

PAIN RELIEVING SPRAY

WITH ESSENTIAL OILS, NATURAL EXTRACTS    and ILEX

PENETRATING, LONG LASTING PAIN RELIEF FROM:

ARTHRITIS - SORE MUSCLES AND JOINTS - BACK PAIN

    Cryotherapy - The Cold Method


2009 Performance Health, Inc., Akron, OH 44310
Product No. - BUSASN16-001 REV 1 NDC 59316-104-XX
Manufactured in the U.S.A.          No Animal Testing
Manufactured in Canada

BiofreezeSpray59ml


BIOFREEZE 
menthol   spray
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)59316-104
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA 
CALENDULA OFFICINALIS FLOWER 
CHAMOMILE 
DIMETHYL SULFOXIDE 
ECHINACEA 
ALCOHOL 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL MYRISTATE 
JUNIPER 
WATER 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
159316-104-1060 mL In 1 BOTTLE, SPRAYNone
259316-104-20118 mL In 1 BOTTLE, SPRAYNone
359316-104-30473 mL In 1 BOTTLE, SPRAYNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2010

Labeler - Performance Health Inc. (794324061)
Establishment
NameAddressID/FEIOperations
LEK Inc.248704645manufacture
Establishment
NameAddressID/FEIOperations
Span Packaging services LLC557434805manufacture
Establishment
NameAddressID/FEIOperations
Cosmetic Essence, LLC.825646862manufacture
Revised: 12/2010Performance Health Inc.