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 reoccur.

If pregnant or breastfeeding: 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

2009 Performance Health, Inc., Akron, OH 44310

       Product No. - BUSAGRA R01 - REV 2

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

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 5mL

BIOFREEZE  menthol   gel

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 59316-101 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Menthol (Menthol) Menthol 0.035 mL  in 5 mL

Inactive Ingredients Ingredient Name Strength CARBOMER HOMOPOLYMER TYPE C   GLYCERIN   METHYLPARABEN   CAMPHOR (SYNTHETIC)   PROPYLENE GLYCOL   SILICON DIOXIDE   TROLAMINE   Water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 59316-101-10 5 mL In 1 PACKET None 2 59316-101-15 89 mL In 1 BOTTLE, WITH APPLICATOR None 3 59316-101-20 118 mL In 1 TUBE None 4 59316-101-21 81 mL In 1 TUBE None 5 59316-101-30 473 mL In 1 BOTTLE, PUMP None 6 59316-101-40 946 mL In 1 BOTTLE, PUMP None 7 59316-101-50 3785 mL In 1 BOTTLE, PUMP None 8 59316-101-25 118 mL In 1 TUBE, WITH APPLICATOR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	12/30/2009

Labeler - Performance Health Inc. (794324061)

Establishment
Name	Address	ID/FEI	Operations
Troy Manufacturing		160075248	manufacture

Establishment
Name	Address	ID/FEI	Operations
Lek Inc.		248704645	manufacture

Establishment
Name	Address	ID/FEI	Operations
Span Packaging Services LLC		557434805	manufacture

Revised: 06/2010Performance Health Inc.