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


Biofreeze Pain Relieving Gel

BIOFREEZE  - menthol gel 
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 Gel


Active Ingredients                                        Purpose

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

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 Gel 5 ML


BIOFREEZE 
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-101
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (Menthol) Menthol 3.5 mL  in 100 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
# Item Code Package Description Multilevel Packaging
1 NDC:59316-101-10 5 mL in 1 PACKET None
2 NDC:59316-101-15 89 mL in 1 BOTTLE, WITH APPLICATOR None
3 NDC:59316-101-20 118 mL in 1 TUBE None
4 NDC:59316-101-21 81 mL in 1 TUBE None
5 NDC:59316-101-30 473 mL in 1 BOTTLE, PUMP None
6 NDC:59316-101-40 946 mL in 1 BOTTLE, PUMP None
7 NDC:59316-101-50 3785 mL in 1 BOTTLE, PUMP None
8 NDC: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 11/03/2010

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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