Biofreeze Foot Pain Relief Set

Biofreeze Foot Pain Relief Set
SPL v5
SPL
SPL Set ID 4a885eef-0364-4655-bccc-7158c76cc5b2
Route
TOPICAL
Published
Effective Date 2022-02-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (100 mg)
Inactive Ingredients
Medium-chain Triglycerides Caprylyl Glycol Cetostearyl Alcohol Dimethicone Gluconolactone Glycerin 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 2021-03-12

Description

Menthol 10%

Purpose

Pain Relieving Cream


Medication Information

Purpose

Pain Relieving Cream

Description

Menthol 10%

Uses:

Temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple 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 areas not more than 3 to 4 times daily;

• Children under 12 years of age: Consult a physician

• wash hands after use with cool water

Active Ingredient:

Menthol 10%

Inactive Ingredients:

Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water

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:

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

Keep Out of Reach of Children:

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

Principal Display Panel 85 G Tube Kit

NDC 59316-002-10

BiOFREEZE ®

COOL THE PAIN

FOOT PAIN

RELIEF SET

MENTHOL-PAIN

RELIEVING CREAM

FOOT ROLLER intended to

relieve foot pain and pain associated

with plantar fasciitis

1 Biofreeze Foot Cream Tube

Net wt 3 OZ (85 g)

+ 1 Foot Roller


Structured Label Content

Uses:

Temporarily relieves minor aches and pains of muscles and joints associated with: • arthritis • simple backache • strains • sprains • bruises

Purpose

Pain Relieving Cream

Warnings

For external use only

Directions:

• Adults and Children 12 years of age and older: Rub a thin film over affected areas not more than 3 to 4 times daily;

• Children under 12 years of age: Consult a physician

• wash hands after use with cool water

Active Ingredient: (Active ingredient:)

Menthol 10%

Inactive Ingredients: (Inactive ingredients:)

Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Dimethicone, Gluconolactone, Glycerin, Glyceryl Stearate, Hydroxyacetophenone, Ilex Paraguariensis Leaf Extract, Iodopropynyl Butylcarbamate, Phenoxyethanol, Polysorbate 60, Sodium Benzoate, Sodium Hydroxide, Sodium Stearoyl Lactylate, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Water

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:)

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

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

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

Principal Display Panel 85 G Tube Kit (PRINCIPAL DISPLAY PANEL - 85 g Tube Kit)

NDC 59316-002-10

BiOFREEZE ®

COOL THE PAIN

FOOT PAIN

RELIEF SET

MENTHOL-PAIN

RELIEVING CREAM

FOOT ROLLER intended to

relieve foot pain and pain associated

with plantar fasciitis

1 Biofreeze Foot Cream Tube

Net wt 3 OZ (85 g)

+ 1 Foot Roller


Advanced Ingredient Data


Raw Label Data

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