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


BIOFREEZE PAIN RELIEVING Singles On-The-Go

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 Singles On-The-Go

Drug Facts

Active Ingredients                                       Purpose

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

Purpose
  Cooling Pain Reliever

Uses: Soothing on-the-go 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, are pregnant or are breastfeeding

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 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: Apply on to the affected areas not more than 4 times daily
  • 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

Ideal size for:
  • Running
  • Hiking
  • Biking
  • Travel
  • Purse
  • Golf Bag
  • Pocket
  • Gym Bag
  • Desk
  • Backpack
  • Car
  • And More...
Anytime . Anywhere.

A no mess topical pain reliever that goes wherever you go: for arthritis, sore muscles, and joint discomfort.

NO NSAID's IBUPROFEN ASPIRIN OR SALICYLATE

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


2011 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

BIOFREEZE PAIN RELIEVING SINGLES ON-THE-GO

10 Single-use application (1ml each)


Singles1Singles2Singles3Singles4Singles5


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:59316-104-50 10 PACKET ( PACKET) in 1 BOX contains a PACKET
1 1 mL in 1 PACKET This package is contained within the BOX (59316-104-50)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 05/19/2011

Labeler - Performance Health Inc. (794324061)
Establishment
Name Address ID/FEI Operations
Tapemark Company 006154595 manufacture

Revised: 05/2011 Performance Health Inc.



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


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