BIOFREEZE description, usages, side effects, indications, overdosage, supplying and lots more!

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BIOFREEZE

Performance Health LLC

BIOFREEZE


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

                    
Menthol USP 4%

Purpose

Cooling Pain Relief

BIOFREEZE 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

BIOFREEZE

MENTHOL GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59316-102
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 40 mg

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:59316-102-10 5 in 1 BOTTLE
2 NDC:59316-102-11 3 in 1 BOTTLE
3 NDC:59316-102-15 89 in 1 BOTTLE, WITH APPLICATOR
4 NDC:59316-102-20 118 in 1 BOTTLE
5 NDC:59316-102-25 118 in 1 BOTTLE, WITH APPLICATOR
6 NDC:59316-102-30 473 in 1 BOTTLE
7 NDC:59316-102-40 946 in 1 BOTTLE
8 NDC:59316-102-50 3785 in 1 CONTAINER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2012-01-03


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Be sure to consult your doctor before taking any medication!
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