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Biofreeze

Performance Health LLC.

Biofreeze Pain Relieving Gel


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Biofreeze Pain Relieving Gel



Active Ingredients

Natural Menthol USP 3.5%

Purpose

Cooling Pain Reliever

Biofreeze Uses

Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis - backache - strains - sprain

Warnings:

For external use only.

Flammable:

Keep away from excessive heat or open flame

Ask a doctor before use if you have:

sensitive skin

  • 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 of 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 the 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

  • carbomer, FD and C blue # 1, FD and C yellow # 5, glycerine, herbal extract (llex paraguariensis), isopropyl alcohol USP, methylparaben, natural camphor USP (for scent), propylene glycol, silicon dioxide, triethanolamine, purified water U

Questions or Comments?

1-330-633-8460

Representative Labeling

Biofreeze

Biofreeze

Menthol GEL

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59316-101
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 35 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
FD&C YELLOW NO. 5
GLYCERIN
ISOPROPYL ALCOHOL
METHYLPARABEN
CAMPHOR (NATURAL)
propylene glycol
SILICON DIOXIDE
TROLAMINE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59316-101-10 5 in 1 PACKET
2 NDC:59316-101-15 89 in 1 BOTTLE, WITH APPLICATOR
3 NDC:59316-101-20 118 in 1 TUBE
4 NDC:59316-101-21 81 in 1 TUBE
5 NDC:59316-101-30 473 in 1 BOTTLE, PUMP
6 NDC:59316-101-40 946 in 1 BOTTLE, PUMP
7 NDC:59316-101-50 3785 in 1 BOTTLE, PUMP
8 NDC:59316-101-25 118 in 1 TUBE, WITH APPLICATOR
9 NDC:59316-101-12 59 in 1 TUBE
10 NDC:59316-101-13 59 in 1 BOTTLE, WITH APPLICATOR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2010-11-03


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Be sure to consult your doctor before taking any medication!
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