Menthol Pain Relief Gel Patch

Manufacturer
Twin Med LLC | DR. SABHARWAL'S WOUND CARE
Effective date
2023-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:31:59

Label at a glance#

ProductMenthol Pain Relief Gel Patch
Active ingredientMENTHOL
Label structure13 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

  • 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

When using this product:

OTC - WHEN USING SECTION

  • 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:

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of children and pets

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

Directions:

DOSAGE & ADMINISTRATION SECTION

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

Other Information:

OTHER SAFETY INFORMATION

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

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Package/Principle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Menthol gel cartonMenthol gel carton

Products#

Every source-derived product name is available through these pages.

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-50255681-502-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ae663032-0dbe-4b23-a423-a163d1311f121607e4ee-ff35-4472-9088-4d77e5013c372023-05-01WarningsExact identifier
spl id: ae663032-0dbe-4b23-a423-a163d1311f12
spl set id: 1607e4ee-ff35-4472-9088-4d77e5013c37

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.