BIOFREEZE - menthol spray
Performance Health LLC

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

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:

Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone, Echinacea,Ethanol , ILEX Paraguarenis, Isopropyl Myristate, Juniper Berry, Water, White Tea

Questions or Comments?

1-800-246-3733

Representative Labeling

BIOFREEZE
menthol spray

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:59316-114
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (MENTHOL)	MENTHOL	105 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ARNICA MONTANA
CALENDULA OFFICINALIS FLOWER
CHAMOMILE
DIMETHYL SULFONE
ECHINACEA, UNSPECIFIED
ALCOHOL
ILEX PARAGUARIENSIS LEAF
ISOPROPYL MYRISTATE
JUNIPERUS COMMUNIS WHOLE
BERRY
WATER

#	Item Code	Package Description
Packaging
1	NDC:59316-114-50	10 in 1 BOX
1		1 mL in 1 PACKET
2	NDC:59316-114-25	118 mL in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/19/2014

Labeler - Performance Health LLC (794324061)

Name	Address	ID/FEI	Business Operations
Establishment
Span Packaging Services LLC		557434805	manufacture(59316-114)

Name	Address	ID/FEI	Business Operations
Establishment
American Spraytech, LLC		137135237	pack(59316-114)

Revised: 2/2014

Document Id: c34ce4b2-bac2-4bf6-b115-3e8aeae00c82

Set id: 4c798b06-6ee5-41d1-8a14-f6889512ade3

Version: 2

Effective Time: 20140219

Performance Health LLC