Biofreeze Pain Relieving Wipes

Dosage form: gel
Ingredients: MENTHOL 10.5mL in 100mL
Labeler: Performance Health Inc.
NDC Code: 59316-204

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.

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



BIOFREEZE PAIN RELIEVING WIPES 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-204
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ILEX PARAGUARIENSIS LEAF 
ARNICA MONTANA 
CALENDULA OFFICINALIS FLOWER 
CHAMOMILE 
DIMETHYL SULFONE 
ECHINACEA 
ISOPROPYL MYRISTATE 
JUNIPER BERRY OIL 
WATER 
Packaging
#Item CodePackage Description
1NDC:59316-204-4024 PACKET (PACKET) in 1 PACKAGE
18 mL in 1 PACKET
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
Span Packaging Services LLC557434805manufacture

Revised: 12/2010
 
Performance Health Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)