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Biofreeze by Performance Health LLC

Dosage form: spray
Ingredients: MENTHOL 105mg in 1mL
Labeler: Performance Health LLC
NDC Code: 59316-114

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

BIOFREEZE

Active Ingredients

Menthol USP 10.5%

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:

Alcohol Denat., Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Dimethyl Sulfone (MSM), Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

Questions or Comments?

info@biofreeze.com or 800-246-3733

Representative Labeling

BIOFREEZE 
menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-114
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL105 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ARNICA MONTANA FLOWER 
CALENDULA OFFICINALIS FLOWER 
GREEN TEA LEAF 
CHAMOMILE 
DIMETHYL SULFONE 
ECHINACEA ANGUSTIFOLIA 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL MYRISTATE 
JUNIPER BERRY 
WATER 
Packaging
#Item CodePackage Description
1NDC:59316-114-5010 PACKET in 1 BOX
11 mL in 1 PACKET
2NDC:59316-114-25118 mL in 1 BOTTLE, SPRAY
3NDC:59316-114-30473 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/19/2014
Labeler - Performance Health LLC (794324061)
Establishment
NameAddressID/FEIOperations
American Spraytech, LLC137135237pack(59316-114)
Establishment
NameAddressID/FEIOperations
Span Packaging Services LLC557434805manufacture(59316-114)

Revised: 02/2016
 
Performance Health LLC

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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.

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