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

BIOFREEZE


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

BIOFREEZE

MENTHOL SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59316-114
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 105 mg

Inactive Ingredients

Ingredient Name Strength
ARNICA MONTANA
CALENDULA OFFICINALIS FLOWER
CHAMOMILE
DIMETHYL SULFONE
ECHINACEA, UNSPECIFIED
ALCOHOL
ILEX PARAGUARIENSIS LEAF
ISOPROPYL MYRISTATE
JUNIPERUS COMMUNIS WHOLE
Berry
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 PACKET
2 NDC:59316-114-25 118 in 1 BOTTLE, SPRAY
3 NDC:59316-114-30 473 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2014-02-19


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Be sure to consult your doctor before taking any medication!
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