Biofreeze Professional Gel

Biofreeze Professional Gel
SPL v6
SPL
SPL Set ID 66ff9726-20da-688a-e053-2a91aa0a59ac
Route
TOPICAL
Published
Effective Date 2018-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg)
Inactive Ingredients
Aloe Vera Leaf Arctium Lappa Root Arnica Montana Flower Fd&c Blue No. 1 Frankincense Calendula Officinalis Flower Green Tea Leaf Carboxypolymethylene Glycerin Ilex Paraguariensis Leaf Isopropyl Alcohol Isopropyl Myristate Melissa Officinalis Leaf Silicon Dioxide .alpha.-tocopherol Acetate Trolamine Water Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-06-03

Description

Menthol USP 5%

Purpose

Cooling Pain Relief


Medication Information

Purpose

Cooling Pain Relief

Description

Menthol USP 5%

Uses:

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

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

Drug Facts

Directions:

Adults and Children 2 years of age and older: Rub a thin film over affected areas not more four times daily; massage not necessary Children under 2 years of age: Consult physician

Package Labeling:

Active Ingredients:

Menthol USP 5%

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

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 liniment; 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 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 Use If You Have:

Sensitive skin


Structured Label Content

Uses:

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

Purpose

Cooling Pain Relief

Warnings:

For external use only

Flammable: Keep away from excessive heat or open flame

Drug Facts

Directions:

Adults and Children 2 years of age and older: Rub a thin film over affected areas not more four times daily; massage not necessary Children under 2 years of age: Consult physician

Package Labeling:

Active Ingredients:

Menthol USP 5%

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Blue 1, Boswellia Carterii Resin Extract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Water, Yellow 5

Questions Or Comments: (Questions or Comments:)

1-800-246-3733

When Using This Product: (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 liniment; 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 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 Use If You Have: (Ask a doctor before use if you have:)

Sensitive skin


Advanced Ingredient Data


Raw Label Data

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