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Biofreeze

Performance Health LLC

Biofreeze Pain Relieving Spray


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients:


Natural Menthol USP 10%

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

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 damages 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


If pregnant or breastfeeding:

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 / Children 12 years and older: Apply on to affected area up to 4 times daily

Children under 12 years of age: Consult a physician

Other Information:

Store in a cool dry place with lid closed tightly

Inactive Ingredients:

Arnica Montana, Calendula,Chamomile, Dimethyl Sulfone (MSM), Echinacea, Ethanol,  Lex Paraguarenis, Isopropyl Myristate, Juniper Berry, Purified Water USP, 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:59316-104
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 100 mg

Inactive Ingredients

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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59316-104-10 59 in 1 BOTTLE, SPRAY
2 NDC:59316-104-20 118 in 1 BOTTLE, SPRAY
3 NDC:59316-104-30 473 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2010-11-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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