biofreeze day & overnight patches

biofreeze day & overnight patches
SPL v3
SPL
SPL Set ID fb5c8f89-a720-ad32-e053-6294a90a2abe
Route
topical
Published
Effective Date 2023-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol, unspecified form (0.3 g)
Inactive Ingredients
lauralkonium chloride tartaric acid polyacrylic acid (450000 mw) carboxymethylcellulose sodium, unspecified edetate disodium glycerin mineral oil polysorbate 80 propylene glycol povidone, unspecified titanium dioxide benzalkonium chloride kaolin dihydroxyaluminum aminoacetate lavender oil petrolatum sodium polyacrylate (2500000 mw) water 1,2-hexanediol phenoxyethanol arnica montana flower ethylhexylglycerin green tea leaf iodopropynyl butylcarbamate frankincense aloe vera leaf

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
otc monograph drug active Since 2023-05-22

Description

Menthol 5% Pain Relieving Patch


Medication Information

Warnings and Precautions

For external use only.

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 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

If pregnant or breast-feeding:

ask a health professional before use.

Keep out of reach of children:

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

Active Ingredient

Menthol 5%

Pain Relieving Patch

Uses

Temporarily relieves minor aches and pains of muscles and

joints associated with:

■ simple backache

■ arthritis

■ strains

■ bruises

■ sprains

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

Other Information

■ store at 20-25°C (68-77°F)

■ store in a cool dry place away from direct sunlight

Description

Menthol 5% Pain Relieving Patch

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Large Patch:

1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower

Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract,

Carboxymethylcellulose Sodium, DihydroxyaluminumAminoacetate, Ethylhexylglycerin,

Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum,

Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol,

PurifiedWater, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

Overnight Relief Patch:

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

Section 51945-4

Section 55105-1

Menthol 5%

Purpose:

Pain Relieving Patch

Questions

1-866-682-4639


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

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 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

If pregnant or breast-feeding:

ask a health professional before use.

Keep out of reach of children:

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

Active Ingredient (55106-9)

Menthol 5%

Pain Relieving Patch

Uses

Temporarily relieves minor aches and pains of muscles and

joints associated with:

■ simple backache

■ arthritis

■ strains

■ bruises

■ sprains

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

Other Information

■ store at 20-25°C (68-77°F)

■ store in a cool dry place away from direct sunlight

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 51727-6 (51727-6)

Large Patch:

1,2-Hexanediol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower

Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract,

Carboxymethylcellulose Sodium, DihydroxyaluminumAminoacetate, Ethylhexylglycerin,

Glycerin, Iodopropynyl Butylcarbamate, Kaolin, Mineral Oil, Petrolatum,

Phenoxyethanol, Polyacrylic Acid, Polysorbate 80, Povidone, Propylene Glycol,

PurifiedWater, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

Overnight Relief Patch:

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Menthol 5%

Purpose:

Pain Relieving Patch

Questions

1-866-682-4639


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)