Biofreeze ®

Biofreeze ®
SPL v3
SPL
SPL Set ID 07be6e88-1850-4d6a-946d-f03830b8c4a2
Route
TOPICAL
Published
Effective Date 2022-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (0.3 g)
Inactive Ingredients
Benzalkonium Chloride Carboxymethylcellulose Sodium, Unspecified Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Kaolin Lauralkonium Chloride Lavender Oil Mineral Oil Petrolatum Polysorbate 80 Propylene Glycol Povidone, Unspecified Tartaric Acid Titanium Dioxide Water Polyacrylic Acid (450000 Mw) Sodium Polyacrylate (2500000 Mw)

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-01

Description

Drug Facts

Purpose

Pain Relieving Patch


Medication Information

Purpose

Pain Relieving Patch

Description

Drug Facts

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Warnings

For external use only.

Directions
  • adults and children 12 years of age and older: Clean and dry affected area pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. Use on 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
Active Ingredient

Menthol 5%

Other Information
  • store at 20-25° (68-77°F)
  • store in a cool dry place away from direct sunlight
Inactive Ingredients

Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride, Lavender Oil, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

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
  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptons 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
Principal Display Panel 4 Patch Pouch Carton

CLINICALLY

RECOMMENDED

NDC 59316-005-04

BIOFREEZE ®

COOL THE PAIN

OVERNIGHT

RELIEF

PATCHES

MENTHOL-TOPICAL

ANALGESIC

Overnight pain relief patch

Scented with lavender

essential oil

Designed to stay on

through the night

Optimal thickness is designed for comfort and flexibility

4 PATCHES

5.125 in x 2.6 in

(13 cm x 6.6 cm) each


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)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purpose

Pain Relieving Patch

Warnings

For external use only.

Directions
  • adults and children 12 years of age and older: Clean and dry affected area pop apart and partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing the patch to skin and leave in place for up to 8 hours. Use on 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
Active Ingredient (Active ingredient)

Menthol 5%

Other Information (Other information)
  • store at 20-25° (68-77°F)
  • store in a cool dry place away from direct sunlight
Inactive Ingredients (Inactive ingredients)

Benzalkonium Chloride, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Lauralkonium Chloride, Lavender Oil, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol, Purified Water, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

Questions Or Comments? (Questions or comments?)

1-866-682-4639

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
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 symptons 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
Principal Display Panel 4 Patch Pouch Carton (PRINCIPAL DISPLAY PANEL - 4 Patch Pouch Carton)

CLINICALLY

RECOMMENDED

NDC 59316-005-04

BIOFREEZE ®

COOL THE PAIN

OVERNIGHT

RELIEF

PATCHES

MENTHOL-TOPICAL

ANALGESIC

Overnight pain relief patch

Scented with lavender

essential oil

Designed to stay on

through the night

Optimal thickness is designed for comfort and flexibility

4 PATCHES

5.125 in x 2.6 in

(13 cm x 6.6 cm) each


Advanced Ingredient Data


Raw Label Data

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