Menthol Pain Relief Gel Patch

Menthol Pain Relief Gel Patch
SPL v1
SPL
SPL Set ID eab185d6-2a54-489d-8114-fe8088624ba4
Route
TOPICAL
Published
Effective Date 2025-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (50 mg)
Inactive Ingredients
Alpha-tocopherol Aluminum Glycinate Aluminum Hydroxide Aluminum Sulfate Carbomer 934 Sodium Borate Silicon Dioxide Dmdm Hydantoin Glycerin Kaolin Polyacrylic Acid (250000 Mw) Polyvinyl Alcohol (100000 Mw) Povidone K27 Propylene Glycol Water Carboxymethylcellulose Sodium Magnesium Disodium Edta Sodium Polyacrylate (2500000 Mw) Sorbitol Monooleate Tartaric Acid Titanium Dioxide Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-04

Description

Menthol 5%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Menthol 5%

Use

Temporarily relieves minor aches and pain of muscles and joints accociated with, simple backache,  arthritis,  strains,  bruises and  sprains

Section 50565-1

keep out of reach of children and pets

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

Section 53414-9

if pregnanat or breast feeding, ask a health professional before use.

Warnings

For external use only

Directions:

Adult and children over 12years:

  • Clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle
  • carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area
  • do not wear a patch for more than 8 hours
  • apply affected area no more than 3 times daily
  • children 12 years or younger: ask a doctor
Do Not Use:
  • more than 1 patch on your body at a time
  • on cut, irritated or swollen skin
  • on puncture wounds or damaged skin
  • for more than one week without consulting a doctor
  • with heating pad
  • on a child under 12 yeas of age with arthritis-like conditions
Active Ingredient

Menthol 5%

Package Label Box

Other Information:

Store at room temperature 20-250C (68-770F)

Questions?  call toll-free 1-844-912-4012

Inactive Ingredients:

Alpha Tocopherol, Aluminum Sulphate, Borax, Carbomer, Colloidal Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone , Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitol Monooleate , Tartaric Acid & Titanium Dioxide, Paraffin

When Using This Product:
  • use only as directed.
  • read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type.
  • do not apply to wounds or damaged, broken or irritated skin
  • do not allow contact with eyes and mucous membranes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets
  • used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if a severe burning sensation occurs, discontinue use immediately.
  • discontinue use at least 1 hour before a bath or shower.
  • do not use immediately after a bath or shower.
Stop Use and Ask A Doctor If:

condition worsens

redness is present over the affected area

excess skin irritation occurs

symptoms persist for more than 7 days or clear up and occur again within a few days

you experience signs of skin injury such as pain, swelling, or blistering where the product was applied


Structured Label Content

Use

Temporarily relieves minor aches and pain of muscles and joints accociated with, simple backache,  arthritis,  strains,  bruises and  sprains

Section 50565-1 (50565-1)

keep out of reach of children and pets

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

Section 53414-9 (53414-9)

if pregnanat or breast feeding, ask a health professional before use.

Purpose

Topical Anesthetic

Warnings

For external use only

Directions:

Adult and children over 12years:

  • Clean and dry affected area
  • remove backing from patch by firmly grasping both ends and gently pulling until back separates in middle
  • carefully remove smaller portion of backing from the patch and apply exposed portion of patch to affected area
  • do not wear a patch for more than 8 hours
  • apply affected area no more than 3 times daily
  • children 12 years or younger: ask a doctor
Do Not Use: (Do not use:)
  • more than 1 patch on your body at a time
  • on cut, irritated or swollen skin
  • on puncture wounds or damaged skin
  • for more than one week without consulting a doctor
  • with heating pad
  • on a child under 12 yeas of age with arthritis-like conditions
Active Ingredient

Menthol 5%

Package Label Box

Other Information:

Store at room temperature 20-250C (68-770F)

Questions?  call toll-free 1-844-912-4012

Inactive Ingredients:

Alpha Tocopherol, Aluminum Sulphate, Borax, Carbomer, Colloidal Silicon Dioxide, DMDM Hydantoin, Glycerin, Kaolin, Polyacrylic Acid, Polyvinyl Alcohol, Polyvinylpyrrolidone , Propylene Glycol, Purified Water, Sodium Carboxymethyl Cellulose, Sodium Ethylenediaminetetraacetic Acid, Sodium Polyacrylate, Sorbitol, Sorbitol Monooleate , Tartaric Acid & Titanium Dioxide, Paraffin

When Using This Product: (When using this product:)
  • use only as directed.
  • read and follow all directions and warnings on this label
  • rare cases of serious burns have been reported with products of this type.
  • do not apply to wounds or damaged, broken or irritated skin
  • do not allow contact with eyes and mucous membranes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets
  • used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if a severe burning sensation occurs, discontinue use immediately.
  • discontinue use at least 1 hour before a bath or shower.
  • do not use immediately after a bath or shower.
Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

condition worsens

redness is present over the affected area

excess skin irritation occurs

symptoms persist for more than 7 days or clear up and occur again within a few days

you experience signs of skin injury such as pain, swelling, or blistering where the product was applied


Advanced Ingredient Data


Raw Label Data

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