Biofreeze Spray

Biofreeze Spray
SPL v12
SPL
SPL Set ID 485c8208-c93b-5b84-e063-6394a90ab77a
Route
TOPICAL
Published
Effective Date 2016-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (130 mg)
Inactive Ingredients
Propylene Glycol Isopropyl Alcohol 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 2026-01-20

Description

Menthol 13%

Purpose

Pain Relieving Spray


Medication Information

Purpose

Pain Relieving Spray

Description

Menthol 13%

Uses

Temporarily relieves minor aches and pains of muscles and joints associated

with: 􀂄 simple backache 􀂄 arthritis 􀂄 strains 􀂄 bruises 􀂄 sprains

Section 42229-5

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

Section 60561-8

􀂄 store at 20-25°C (68-77°F)

􀂄 store in a cool dry place away from direct sunlight

Purpose:

Pain Relieving Spray

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

Wash hands after use with cool water

Package Labeling:

Active Ingredients:

Menthol 13%

Inactive Ingredients

Alcohol, Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis

Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract, Echinacea Angustifolia Extract, Glycerin,

Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Juniperus Communis Fruit

Extract, Methylsulfonylmethane, Propylene Glycol, PurifiedWater, Tert-Butyl Alcohol

Questions Or Comments:

1-866-682-4639

When Using This Product

􀂄 use only as directed

􀂄 avoid contact with the eyes or on mucous membranes

􀂄 do not apply to wounds or damaged skin

􀂄 do not apply to irritated skin or if excessive irritation develops

􀂄 do not bandage tightly or 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 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

Temporarily relieves minor aches and pains of muscles and joints associated

with: 􀂄 simple backache 􀂄 arthritis 􀂄 strains 􀂄 bruises 􀂄 sprains

Section 42229-5 (42229-5)

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

Section 60561-8 (60561-8)

􀂄 store at 20-25°C (68-77°F)

􀂄 store in a cool dry place away from direct sunlight

Purpose:

Pain Relieving Spray

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

Wash hands after use with cool water

Package Labeling:

Active Ingredients:

Menthol 13%

Inactive Ingredients

Alcohol, Arnica Montana Flower Extract, Calendula Officinalis Flower Extract, Camellia Sinensis

Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract, Echinacea Angustifolia Extract, Glycerin,

Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Juniperus Communis Fruit

Extract, Methylsulfonylmethane, Propylene Glycol, PurifiedWater, Tert-Butyl Alcohol

Questions Or Comments: (Questions or Comments:)

1-866-682-4639

When Using This Product

􀂄 use only as directed

􀂄 avoid contact with the eyes or on mucous membranes

􀂄 do not apply to wounds or damaged skin

􀂄 do not apply to irritated skin or if excessive irritation develops

􀂄 do not bandage tightly or use with heating pad or device

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

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