Biofreeze Roll-On description, usages, side effects, indications, overdosage, supplying and lots more!

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Biofreeze Roll-On

Performance Health Inc.

Biofreeze Roll-On


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts


Active Ingredients

Menthol USP 4%

Purpose


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 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 skin 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 breast-feeding:

Ask a health professional before use

Keep out of reach of children:


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:


Inactive Ingredients:


Questions or Comments

1-800-246-3733


Product Label

Biofreeze Roll-On

Biofreeze Roll-On

MENTHOL GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59316-205
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
Frankincense
CALENDULA OFFICINALIS FLOWER
GREEN TEA LEAF
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 89 in 1 BOTTLE, WITH APPLICATOR
2 NDC:59316-205-10 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-01-17


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