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


Biofreeze Pain Relieving Wipe

BIOFREEZE PAIN RELIEVING WIPES  - 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 Wipe

Active Ingredients Purpose

Natural Menthol USP 10.5 percent 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 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, symptoms persist more than 7 days, or clear up and reoccur

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 and older : Wipe onto affected area. Discard wipe and clean hands following use. Do not use more than 4 times daily.

Children under 12 years of age: Consult physician


Other Information

Store in a cool dry place

arnica Montana, calendula, chamomile, dimethyl sulfone msm

echinacea,ethanol,ilex paraguariensis,

isopropyl myristate, juniper berry, purified water usp, white tea

Questions

1 800 246 3733

No Animal Testing 2009 Performance Health, Inc. Akronn OH 44310

Manufactured in the U.S.A.

WITH SOOTHING NATURAL MENTHOL AND ILEX

BIOFREEZE

PAIN RELIEVING WIPES

HIGH POTENCY MAXIMUM INTENSITY

ON THE GO , FAST ACTING INTEGRATED COOLING TECHNOLOGY


BiofreezeInnerPackage


BIOFREEZE PAIN RELIEVING WIPES 
menthol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59316-204
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 10.5 mL  in 100 mL
Inactive Ingredients
Ingredient Name Strength
ILEX PARAGUARIENSIS LEAF  
ARNICA MONTANA  
CALENDULA OFFICINALIS FLOWER  
CHAMOMILE  
DIMETHYL SULFONE  
ECHINACEA  
ISOPROPYL MYRISTATE  
JUNIPER BERRY OIL  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59316-204-40 24 PACKET ( PACKET) in 1 PACKAGE contains a PACKET
1 8 mL in 1 PACKET This package is contained within the PACKAGE (59316-204-40)

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
Span Packaging Services LLC 557434805 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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