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Biofreeze by Performance Health LLC

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 Spray

Active Ingredients:


Natural Menthol USP 10%

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 damages 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 / Children 12 years and older: Apply on to affected area up to 4 times daily

Children under 12 years of age: Consult a physician

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone (MSM), Echinacea, Ethanol,  Lex Paraguarenis, Isopropyl Myristate, Juniper Berry, Purified Water USP, White Tea

Questions or Comments?

1-800-246-3733

Representative Labeling
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 SULFOXIDE 
ECHINACEA, UNSPECIFIED 
ALCOHOL 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL MYRISTATE 
JUNIPERUS COMMUNIS WHOLE 
WATER 
Packaging
#Item CodePackage Description
1NDC:59316-104-1059 mL in 1 BOTTLE, SPRAY
2NDC:59316-104-20118 mL in 1 BOTTLE, SPRAY
3NDC:59316-104-30473 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2010
Labeler - Performance Health LLC (794324061)
Establishment
NameAddressID/FEIOperations
Span Packaging services LLC557434805manufacture(59316-104)
Establishment
NameAddressID/FEIOperations
Cosmetic Essence, LLC.825646862manufacture(59316-104)

Revised: 06/2014
 
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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