Skip to Content

← See all Biofreeze brands

Biofreeze by Performance Health LLC

Medically reviewed on February 23, 2018

Dosage form: spray
Ingredients: MENTHOL 100mg in 1mL
Labeler: Performance Health LLC
NDC Code: 59316-104

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 Singles On-The-Go

Drug Facts

Active Ingredients

Menthol USP 10%

Purpose

Cooling Pain Relief

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 Using 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.

Keep out of reach of children:

If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Ask a doctor before use if you have: sensitive skin, are pregnant or are breastfeeding

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 out of direct sunlight.

Inactive Ingredients:

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.

PRESS TAB PULL OUT   CONVENIENT DISPENSER BOX

BIOFREEZE PAIN RELIEVING Singles
  1. Hold on Opposite Sides
  2. Fold Sides Down Away From Pad
  3. Apply  Squeeze Liquid Into Pad and Apply


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

BIOFREEZE PAIN RELIEVING Singles  On-The-Go  HANDS FREE SINGLE USE  10 Single-use applications (1 mL each)  2011 Performance Health, LLC  1245 Home Avenue, Akron, OH 44310

Product Label

BIOFREEZE  
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-104
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA 
CALENDULA OFFICINALIS FLOWER 
CHAMOMILE 
DIMETHYL SULFONE 
ECHINACEA, UNSPECIFIED 
ALCOHOL 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL MYRISTATE 
JUNIPERUS COMMUNIS WHOLE 
BERRY 
WATER 
Packaging
#Item CodePackage Description
1NDC:59316-104-5010 PACKET (PACKET) in 1 BOX
11 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/19/201112/31/2018
Labeler - Performance Health LLC (794324061)
Establishment
NameAddressID/FEIOperations
Tapemark Company006154595manufacture(59316-104)

 
Performance Health LLC

← See all Biofreeze brands

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