Drug Labeling and Warnings

Drug Details [pdf]

PAIN RELIEVING PATCH- menthol patch 
Essentials Biotech Co, Ltd

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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Active Ingredients Purpose

Menthol 5% .......................Topical Analgesic

Uses

Temporarily relieves minor aches and pains of muscles and joints due to

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

For external use only

Do not use

  • on wounds or damaged skin
  • if you are allergic to any ingredients of this product
  • with a heating pad

When using this product

  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes, mucous membranes or rashes

Stop use and ask a doctor if

  • excessive redness or irritation is present
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

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.

Directions

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove film from patch and apply to the skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

Children under 12 years of age: consult a doctor

Other information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Glycerin, Sodium polyacrylate, Aluminum Hydroxide, Disodium EDTA, Titanium Dioxide, Water, Tartaric Acid, Polyvinyl alcohol, Caster oil, Polysorbate, Isopropyl myristate, Kaolin

Manufactured by:

Essentials Biotech Co., Ltd.

Address: No.8 Plant, No. 26 Qinghua Rd, Xuguan

Industrial Zone, Suzhou, Jiangsu 21515, China (CHN)

7178a849-5e73-12f2-e053-2a95a90a4858

PAIN RELIEVING PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71183-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TARTARIC ACID (UNII: W4888I119H)  
CASTOR OIL (UNII: D5340Y2I9G)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
WATER (UNII: 059QF0KO0R)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
Product Characteristics
Color    Score    
ShapeSQUARESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71183-102-035 in 1 BOX07/20/201803/01/2019
10.05 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/20/201803/01/2019
Labeler - Essentials Biotech Co, Ltd (544530742)
Registrant - Essentials Biotech Co, Ltd (544530742)

Revised: 11/2019