PATCH GOOD SENSE- menthol patch 
Good Sense

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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Extra Strength Cool and 'n Heat Patch For Arm, Neck & Leg

Active Ingredient

Menthol 5.00%

Uses

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

  • Arthritis          
  • Simple Backache            
  • Strains
  • Bursitis        
  • Tendonitis               
  • Bruises
  • Cramps

Warnings
For external use only.

When using this product

  • Use only as directed
  • Avoid contact with eyes and mucous membranes
  • Do no apply to wounds or damaged skin
  • Do not bandage tightly or use a heating pad

Stop use and ask doctor if

  • Excessive redness or irritation is present
  • Condition worsens
  • Pain persists for more than 7 days
  • Symptoms clear up and occur again within a few days

If pregnant of 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 and over: apply patch to affected area as needed but not more than 4 times daily
  • Children under 12 years: ask a doctor
  • For easy application: grasy both ends of pad firmly, pull at both ends. Stretch pad until the backing separates. Remove protective film while appliying pad directly to site of pain.

Inactive Ingredients

Alcohol, Aluminum Hydroxide, Borneol, Camphor, Disodium EDTA, Glycerin, Methylparaben, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

image description

PATCH  GOOD SENSE
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL775 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BORNEOL (UNII: M89NIB437X)  
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50804-024-085 in 1 BOX11/02/201603/01/2018
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/02/201603/05/2018
Labeler - Good Sense (076059836)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel529128763manufacture(50804-024)

Revised: 3/2018
Document Id: d9cbc20c-9ac4-4000-a2c3-9175b3200d9f
Set id: 0da2753f-3e43-47d7-8f9f-345231d58157
Version: 4
Effective Time: 20180306
 
Good Sense