BIOFREEZE PAIN RELIEF- menthol, unspecified form cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)
Available from:
Performance Health LLC
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains
Authorization status:
OTC monograph not final
Authorization number:
59316-307-10

BIOFREEZE PAIN RELIEF- menthol, unspecified form cream

Performance Health LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Biofreeze Pain Relief Cream

Drug Facts

Active Ingreidents

Menthol 10%

Purpose

Cooling Pain Relief

Us es

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis,

backache, strains, and sprains

Warnings

For external use only.

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 irritation develops

Do not bandage

Wash hands after use with cool water

Do not use with heating pad or device

Store in a cool dry place

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 breat-feeding:

Ask a health professional before use

Keep out of reach of children:

If accidentally ingested, get medical help or contact a Poison Contropl Center immediately

Directions

Adults and children 12 years of age and older: Rub a thin film over affected areas not more than 4

times daily; massage not necessary.

Childern under 12 years of age: Consult physician

Inactive Ingredients

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Diazolidinyl Urea, Dimethicone, Gluconolactone,

Glycerin, Glyceryl Stearate, Ilex Paraguariensis Leaf Extract, Iodopropynyl butylcarbamate,

Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA,

Tocopheryl Acetate, Vitis Vinifera (Grape) seed Oil, Water

Questions or Comments

1-800-246-3733

Package Labeling:

BIOFREEZE PAIN RELIEF

menthol, unspecified form cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:59 316 -30 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A) (MENTHOL -

UNII:L7T10 EIP3A)

MENTHOL, UNSPECIFIED

FORM

10 0 mg

in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

TRICAPRIN (UNII: O1PB8 EU9 8 M)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

GLUCO NO LACTO NE (UNII: WQ29 KQ9 POT)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

ILEX PARAGUARIENSIS LEAF (UNII: 1Q9 53B4O4F)

IO DO PRO PYNYL BUTYLCARBAMATE (UNII: 6 0 3P14DHEB)

Performance Health LLC

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

SO DIUM STEARO YL LACTYLATE (UNII: IN9 9 IT31LN)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

GRAPE SEED O IL (UNII: 9 30 MLC8 XGG)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:59 316 -30 7-10

1 in 1 CARTON

0 3/0 7/20 18

1

8 9 mL in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 3/0 7/20 18

Labeler -

Performance Health LLC (794324061)

Revised: 5/2019

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