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Biofreeze by Preferred Pharmaceuticals Inc.

Medically reviewed on May 15, 2017

Dosage form: gel
Ingredients: MENTHOL, UNSPECIFIED FORM 40mg in 1mL
Labeler: Preferred Pharmaceuticals Inc.
NDC Code: 68788-6457

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

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:
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 irritated 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 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:
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

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

Representative Labeling
BIOFREEZE 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-6457(NDC:59316-102)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (MENTHOL) MENTHOL, UNSPECIFIED FORM40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
ARNICA MONTANA FLOWER 
ARCTIUM LAPPA ROOT 
FRANKINCENSE 
CALENDULA OFFICINALIS FLOWER 
GREEN TEA LEAF 
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 
Packaging
#Item CodePackage Description
1NDC:68788-6457-1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/16/2016
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIOperations
Preferred Pharmaceuticals Inc.791119022RELABEL(68788-6457)

 
Preferred Pharmaceuticals Inc.

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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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