BIOFREEZE Pain Relieving

BIOFREEZE PAIN RELIEVING - menthol gel
Performance Health Inc.

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.

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Active Ingredients Purpose

Natural Menthol USP 3.5%.....................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

Other Information: Store in a cool dry place with lid closed tightly

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 uses with heating pad or device

Stop Use And Ask A Doctor If: Condition worsens, or of 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 the reach of children: If accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions - Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary.
- Children under 2 years of age : Consult physician

Inactive Ingredients: carbomer, FD and C blue Number 1, FD and C yellow Number 5, glycerine, herbal extract llex paraguariensis, isopropyl alcohol USP, methylparaben, natural camphor USP for scent, propylene glycol, silicon dioxide, triethanolamine, purified water USP

Questions or Comments 1-800-246-3733

2009 Performance Health, Inc., Akron, OH 44310

Product No. - BUSAGRA R01 - REV 2

No Animal Testing Manufactured in the U.S.A.

PENETRATING, LONG LASTING PAIN RELIEF FROM:

ARTHRITIS - SORE MUSCLES and JOINTS - BACK PAIN

BIOFREEEZE

PAIN RELIEVING gel
WITH SOOTHING NATURAL MENTHOL and ILEX

Cryotherapy - The Cold Method 5mL

BioA BioB

BIOFREEZE PAIN RELIEVING
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59316-201
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (Menthol)	Menthol	35 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C
GLYCERIN
METHYLPARABEN
CAMPHOR (SYNTHETIC)
PROPYLENE GLYCOL
SILICON DIOXIDE
TROLAMINE
Water

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:59316-201-12	59 mL in 1 TUBE	None
2	NDC:59316-201-17	59 mL in 1 BOTTLE, WITH APPLICATOR	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/12/2011	01/02/2013

Labeler - Performance Health Inc. (794324061)

Establishment
Name	Address	ID/FEI	Operations
Span Packaging Services LLC		557434805	manufacture

Revised: 12/2012 Performance Health Inc.