Biofreeze Overnight Relief Cream

Biofreeze Overnight Relief Cream
SPL v7
SPL
SPL Set ID 10a8face-47da-ebbe-e063-6294a90a42fe
Route
TOPICAL
Published
Effective Date 2024-02-08
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 2024-02-15

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 •bruises

Warnings:

For external use only

Directions:



adults and children 12 years of age and older: rub a thin film over affected area not more

than 3 to 4 times daily

children under 12 years of age: consult a physician



■ wash hands after use with cool water

Package Labeling:

Active Ingredients:

Menthol USP 10%

Inactive Ingredients:



Alcohol, Calcium Gluconate, Caprylic/Capric Triglyceride,

Caprylyl Glycol, Cetostearyl Alcohol, Dimethicone, Edetate Sodium, Fragrance, Gluconolactone, Glycerin,

Glyceryl Stearate, Grapeseed Oil Refined, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract,

Iodopropynyl Butylcarbamate, Isopropyl Alcohol, PEG-4 Laurate, Phenoxyethanol, Polysorbate 60,

PurifiedWater, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate

Questions Or Comments:

1-800-246-3733

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

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


Structured Label Content

Uses:

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

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 area not more

than 3 to 4 times daily

children under 12 years of age: consult a physician



■ wash hands after use with cool water

Package Labeling:

Active Ingredients:

Menthol USP 10%

Inactive Ingredients:



Alcohol, Calcium Gluconate, Caprylic/Capric Triglyceride,

Caprylyl Glycol, Cetostearyl Alcohol, Dimethicone, Edetate Sodium, Fragrance, Gluconolactone, Glycerin,

Glyceryl Stearate, Grapeseed Oil Refined, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract,

Iodopropynyl Butylcarbamate, Isopropyl Alcohol, PEG-4 Laurate, Phenoxyethanol, Polysorbate 60,

PurifiedWater, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tocopheryl Acetate

Questions Or Comments: (Questions or Comments:)

1-800-246-3733

When Using This Product: (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

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


Advanced Ingredient Data


Raw Label Data

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