BIOFREEZE  - menthol gel 
Performance Health Inc.

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Biofreeze Pain Relieving Gel


Active Ingredients                                        Purpose

Natural Menthol USP 3.5%.....................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

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


Ask a doctor before use if you have: sensitive skin



When Using This Product: - Avoid contact with the eyes or mucous membranes - Do not apply to wounds or damaged 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 uses with heating pad or device

Stop Use And Ask A Doctor If: Condition worsens, or of symptoms persist for more than 7 days, or clear up and recur.

If pregnant or breast-feeding: Ask a health professional before use.


Keep out of the reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions - Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
- Children under 2 years of age : Consult physician


Inactive Ingredients: carbomer, FD and C blue Number 1, FD and C yellow Number 5, glycerine, herbal extract llex paraguariensis, isopropyl alcohol USP, methylparaben, natural camphor USP for scent, propylene glycol, silicon dioxide, triethanolamine, purified water USP


Questions or Comments 1-800-246-3733

Formulated For Authorized Distribution Through Hands-On Health Professionals For The Patients, Clients, and Athletes Under Their Care

2009 Performance Health, Inc., 1245 Home Avenue, Akron, OH 44310

       Product No. - BUSATO4-001 - REV 2 - NDC 59316-101-20

Manufactured in the U.S.A.                         No Animal Testing

PENETRATING, LONG LASTING PAIN RELIEF FROM:

ARTHRITIS -  SORE MUSCLES and JOINTS - BACK PAIN

BIOFREEEZE

PAIN RELIEVING GEL
WITH SOOTHING NATURAL MENTHOL and ILEX

Cryotherapy - The Cold Method 4 fl oz / 118 mL

Biofreeze Gel 118 ML


BIOFREEZE 
menthol   gel
Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)59316-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol0.035 mL  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE C 
GLYCERIN 
METHYLPARABEN 
CAMPHOR (SYNTHETIC) 
PROPYLENE GLYCOL 
SILICON DIOXIDE 
TROLAMINE 
Water 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
159316-101-00118 mL In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/30/2009

Labeler - Performance Health Inc. (794324061)
Establishment
NameAddressID/FEIOperations
Troy Manufacturing160075248manufacture
Establishment
NameAddressID/FEIOperations
Span Packaging Services LLC557434805manufacture
Revised: 06/2010Performance Health Inc.