Menthol Pain Relief Gel Patch

Menthol Pain Relief Gel Patch by

Drug Labeling and Warnings

Menthol Pain Relief Gel Patch by is a Otc medication manufactured, distributed, or labeled by Twin Med LLC, DR. SABHARWAL'S WOUND CARE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MENTHOL PAIN RELIEF GEL PATCH- menthol pain relief gel patch patch 
Twin Med LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Menthol Pain Relief Gel Patch

Active Ingredient

Menthol 5%

Purpose

Topical Anesthetic

Use

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

Warnings

For external use only

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

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

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

keep out of reach of children and pets

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

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

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

Package/Principle Label

Menthol gel carton

MENTHOL PAIN RELIEF GEL PATCH 
menthol pain relief gel patch patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55681-502
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg
Inactive Ingredients
Ingredient NameStrength
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ALUMINUM SULFATE (UNII: 34S289N54E)  
CARBOMER 934 (UNII: Z135WT9208)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)  
POVIDONE K27 (UNII: H7AGY1OJO8)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
SORBITOL (UNII: 506T60A25R)  
SORBITOL MONOOLEATE (UNII: 658271J00C)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Product Characteristics
ColorwhiteScore    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55681-502-153 in 1 BOX05/01/2023
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2023
Labeler - Twin Med LLC (009579330)
Registrant - Twin Med LLC (009579330)
Establishment
NameAddressID/FEIBusiness Operations
DR. SABHARWAL'S WOUND CARE862184668manufacture(55681-502)

Revised: 5/2023
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