PAINKOOLERS- menthol, capsaicin patch 
Pure Source, LLC

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PainKoolers Pain Relief Patch

DRUG FACTS

ACTIVE INGREDIENTS:

Menthol  5.00%

Capsaicin 0.0375%

Purpose

Analgesic/Counterirritant

External Analgesic

USES:

For the temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, sprains, bruises and strains.

WARNINGS:

Do not use

  • on wounds or damaged skin.
  • in combination with any other external analgesic products.
  • in combination with any external heat source.
  • on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.
  • if you are allergic to Menthol.

Keep out of reach of children.

Consult physician for children under 12.

Stop use and ask a doctor

  • if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
  • if rash, itching or excessive skin irritation occurs.

DIRECTIONS:

OTHER INGREDIENTS:

Water, Glycerine, Sodium Polyacrylate, Polysorbate 80Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diazolidinyl Urea, Methylparaben, Iodoproynyl Butylcabamate, Propylparaben.

Store

 below 25 degrees.  Avoid direct sunlight.

Product Label

PainKoolers Topical Analgesic patch Menthol 5% Capsaicin 0.0375% Designed for better mobility 5 Patches

PainKoolersPatch

PAINKOOLERS 
menthol, capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-828
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65121-828-055 in 1 BOX02/10/2017
18 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/30/2014
Labeler - Pure Source, LLC (080354456)

Revised: 11/2023
Document Id: 09d70e71-d1f1-2749-e063-6294a90abd05
Set id: f8f8d9b6-0781-4a42-ab03-3fd2e8ea59ba
Version: 8
Effective Time: 20231110
 
Pure Source, LLC