BIOFREEZE  - 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                      
Menthol USP 4%

Purpose
Cooling Pain Relief

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:

Stop use and ask a doctor if: Condition worsens, or if symptoms  persist for more than 7 days, or clear up and recur

If pregnant or breast-feeding: 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

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

Inactive Ingredients: Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Arctium Lappa Root (Burdock) Extract, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Carbomer, Camellia Sinensis Leaf Extract , Camphor USP, Glycerin, Ilex Paraguariensis Leaf Extract (Green Tea), Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silicon Dioxide, Tocopheryl (Vitamine E) Acetate, Triethanolamine, Purified Water USP, Blue 1, Yellow 5

Questions or Comments 1-800-246-3733

Formulated For Authorized Distribution Through Hands-On Health Professionals For The Patients, Clients, and Athletes Under Their Care

Manufactured in the U.S.A

No  Animal Testing  

NO NSAIDS, IBUPROFEN, ASPIRIN OR SALICYLATE

2011 Performance Health, Inc. 1245 Home Avenue, Akron, OH 44310

www.biofreeze.com  11815

REV 06/11  NDC 59316-103-20

for arthritis, back pain, sore muscles and joints

GEL

BIOFREEZE

COLD THERAPY PAIN RELIEF

SOOTHING MENTHOL - VANISHING SCENT - PARABEN-FREE

4 fl oz / 118 mL


Biofreeze Gel 102


BIOFREEZE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59316-102
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL4 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARNICA MONTANA FLOWER 
ARCTIUM LAPPA ROOT 
FRANKINCENSE 
CALENDULA OFFICINALIS FLOWERING TOP 
CAMELLIA SINENSIS FLOWER 
CAMPHOR (SYNTHETIC) 
GLYCERIN 
ILEX PARAGUARIENSIS LEAF 
ISOPROPYL ALCOHOL 
ISOPROPYL MYRISTATE 
MELISSA OFFICINALIS LEAF 
SILICON DIOXIDE 
ALPHA-TOCOPHEROL ACETATE 
TROLAMINE 
WATER 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:59316-102-105 mL in 1 BOTTLENone
2NDC:59316-102-113 mL in 1 BOTTLENone
3NDC:59316-102-1589 mL in 1 BOTTLE, WITH APPLICATORNone
4NDC:59316-102-20118 mL in 1 BOTTLENone
5NDC:59316-102-25118 mL in 1 BOTTLE, WITH APPLICATORNone
6NDC:59316-102-30473 mL in 1 BOTTLENone
7NDC:59316-102-40946 mL in 1 BOTTLENone
8NDC:59316-102-503785 mL in 1 CONTAINERNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34801/03/2012

Labeler - Performance Health Inc. (794324061)
Establishment
NameAddressID/FEIOperations
Span Packaging Services LLC557434805manufacture
Establishment
NameAddressID/FEIOperations
Cosmetic Essence, LLC825646862manufacture

Revised: 01/2012 Performance Health Inc.