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Name:Biofreeze
Manufacturer:Performance Health Inc.
Category:Over-the-counter (OTC) Marketed Drugs


Biofreeze Pain Relieving Spray

BIOFREEZE  - menthol spray 
Performance Health 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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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 Type HUMAN OTC DRUG Item Code (Source) NDC:59316-104
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 10 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ARNICA MONTANA  
CALENDULA OFFICINALIS FLOWER  
CHAMOMILE  
DIMETHYL SULFOXIDE  
ECHINACEA  
ALCOHOL  
ILEX PARAGUARIENSIS LEAF  
ISOPROPYL MYRISTATE  
JUNIPER  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59316-104-10 60 mL in 1 BOTTLE, SPRAY None
2 NDC:59316-104-20 118 mL in 1 BOTTLE, SPRAY None
3 NDC:59316-104-30 473 mL in 1 BOTTLE, SPRAY None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/01/2010

Labeler - Performance Health Inc. (794324061)
Establishment
Name Address ID/FEI Operations
LEK Inc. 248704645 manufacture
Establishment
Name Address ID/FEI Operations
Span Packaging services LLC 557434805 manufacture
Establishment
Name Address ID/FEI Operations
Cosmetic Essence, LLC. 825646862 manufacture

Revised: 12/2010 Performance Health Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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