Biofreeze Spray

Biofreeze Spray
SPL v11
SPL
SPL Set ID 00bb462a-27d0-6f74-e063-6394a90a90ec
Route
TOPICAL
Published
Effective Date 2016-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (105 mg)
Inactive Ingredients
Isopropyl Alcohol Denatonium Benzoate Tert-butyl Alcohol Arnica Montana Flower Calendula Officinalis Flower Chamomile Dimethyl Sulfone Alcohol Ilex Paraguariensis Leaf Isopropyl Myristate Juniper Berry Water Echinacea Angustifolia Whole Tea Leaf Oil Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-01
Description

Menthol 10.5%

Purpose

Cooling Pain Relief

Medication Information

Purpose

Cooling Pain Relief

Description

Menthol 10.5%

Uses

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

Section 42229-5

Contents Under Pressure. Do Not Punture Or Incinerate Do Not Store At Temperature Above 120°F

Purpose:

Cooling Pain Relief

Warnings

For external use only.

Drug Facts


Flammable:

Keep away from excessive heat or open flame.

Directions:

Adults and children 12 years of age and older:Spray on to the affected areas not more than 4 times daily; massage not necessary

Children under 12 years of age:Consult physician

Package Labeling:

Active Ingredients:

Menthol 10.5%

Inactive Ingredients

Alcohol, Arnica Montana Flower Extract, Calendula Officinalis

Flower Oil, Camellia Sinensis Leaf Oil, Chamomilla Recutita

(Matricaria) Flower Extract, Denatonium Benzoate, Echinacea

Angustifolia Extract, Glycerin, Ilex Paraguariensis Leaf Extract,

Isopropyl Alcohol, Isopropyl Myristate, Juniperus Communis

Fruit Extract, Methylsulfonylmethane, Purified Water,

Tert-Butyl Alcohol

Questions Or Comments:

1-800-246-3733

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; 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 Breast Feeding:

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

Ask A Doctor Before Using If You Have:

■ you experience pain, swelling or blistering of the skin

■ condition worsens, or if symptoms persist for more

than 7 days or clear up and occur again within a few

days

■ arthritic pain persists for more than 10 days, or

redness is present

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Contents Under Pressure. Do Not Punture Or Incinerate Do Not Store At Temperature Above 120°F

Purpose:

Cooling Pain Relief

Warnings

For external use only.

Drug Facts


Flammable:

Keep away from excessive heat or open flame.

Directions:

Adults and children 12 years of age and older:Spray on to the affected areas not more than 4 times daily; massage not necessary

Children under 12 years of age:Consult physician

Package Labeling:

Active Ingredients:

Menthol 10.5%

Inactive Ingredients

Alcohol, Arnica Montana Flower Extract, Calendula Officinalis

Flower Oil, Camellia Sinensis Leaf Oil, Chamomilla Recutita

(Matricaria) Flower Extract, Denatonium Benzoate, Echinacea

Angustifolia Extract, Glycerin, Ilex Paraguariensis Leaf Extract,

Isopropyl Alcohol, Isopropyl Myristate, Juniperus Communis

Fruit Extract, Methylsulfonylmethane, Purified Water,

Tert-Butyl Alcohol

Questions Or Comments: (Questions or Comments:)

1-800-246-3733

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; Store in a cool dry place

Stop Use and Ask A Doctor If: (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 Breast Feeding: (If pregnant or breast-feeding:)

Ask a health professional before use

Keep Out of Reach of Children: (Keep out of reach of children:)

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

Ask A Doctor Before Using If You Have: (Ask a Doctor Before using If You have:)

■ you experience pain, swelling or blistering of the skin

■ condition worsens, or if symptoms persist for more

than 7 days or clear up and occur again within a few

days

■ arthritic pain persists for more than 10 days, or

redness is present

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:54.442025 · Updated: 2026-03-14T23:09:57.827589