Biofreeze Cream

Biofreeze Cream
SPL v6
SPL
SPL Set ID a227213b-e89f-7144-e053-2a95a90a7e74
Route
TOPICAL
Published
Effective Date 2021-12-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (100 mg)
Inactive Ingredients
Alcohol Cetostearyl Alcohol Isopropyl Alcohol Peg-4 Laurate Glycerin Calcium Gluconate Medium-chain Triglycerides Caprylyl Glycol Dimethicone Gluconolactone Glyceryl Monostearate Hydroxyacetophenone Ilex Paraguariensis Leaf Iodopropynyl Butylcarbamate Phenoxyethanol Polysorbate 60 Sodium Benzoate Sodium Hydroxide Sodium Stearoyl Lactylate Edetate Sodium .alpha.-tocopherol Acetate Grape Seed Oil Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-21

Description

Menthol USP 10%

Purpose

Cooling Pain Relief


Medication Information

Purpose

Cooling Pain Relief

Description

Menthol USP 10%

Uses:

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

Warnings:

For external use only

Directions:

Adults and Children 12 years of age and older:Rub a thin film over affected areas not more four times daily; massage not necessary

Children under 12 years of age:Consult physician

Package Labeling:

Active Ingredients:

Menthol USP 10%

Inactive Ingredients:

Caprylic/Capric Triglyceride, Caprylyl Glycol, Alcohol, Dimethicone, Gluconolactone Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water,Calcium Gluconate, Cetostearyl Alcohol, Edetate Sodium, Isopropyl Alcohol, PEG-4 Laurate

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

If Pregnant Or Breastfeeding:

Ask a health professional before use

Stop Use and Ask A Doctor If:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

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: • arthritis • backache • strains • sprains

Purpose

Cooling Pain Relief

Warnings:

For external use only

Directions:

Adults and Children 12 years of age and older:Rub a thin film over affected areas not more four times daily; massage not necessary

Children under 12 years of age:Consult physician

Package Labeling:

Active Ingredients:

Menthol USP 10%

Inactive Ingredients:

Caprylic/Capric Triglyceride, Caprylyl Glycol, Alcohol, Dimethicone, Gluconolactone Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water,Calcium Gluconate, Cetostearyl Alcohol, Edetate Sodium, Isopropyl Alcohol, PEG-4 Laurate

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 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

If Pregnant Or Breastfeeding: (If pregnant or breastfeeding:)

Ask a health professional before use

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

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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