MEDICATED PAIN RELIEF- menthol patch 
Kareway Product, Inc.

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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Pure-Aid Pain Relief Patch

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with:

Warnings

For external use only

When using this product

  • use only as directed
  • do not bandage tightly or use a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin
  • do not use if you are allergic to any ingredients of this product

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

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 over 12 years:

Carefully remove backing from patch

Apply one patch to affected area

Repeat as necessary, but no more than 4 times daily.

Children 12 years or younger:

ask a doctor

Inactive ingredients

aluminium glycinate, 1,3-butylene glycol, carboxymethyl cellulose sodium, concentrated glycerin, diethylene glycomonoethyl ether, disodium edetate, methyl parahydroxybenozate, polyacrylic acid solution, polysorbate 90, propyl parahydroxybenzoate, purified water, sodium polyacrylate, tartaric acid, titanium oxide

package label


Pain Relief Medicated Patch

carton

MEDICATED PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL428.5 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
1,3-BUTYLENE GLYCOL 1-PROPIONATE (UNII: 17U77WTV66)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
COBALT DISODIUM EDETATE (UNII: 3EY1Y2QRLI)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0301-51 in 1 CARTON12/01/2011
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 finalpart34809/12/2011
Labeler - Kareway Product, Inc. (121840057)

Revised: 2/2023
Document Id: f4ef5e2d-27ba-ca48-e053-2a95a90a8ab1
Set id: 2913d7ac-fcf6-4d00-8083-532166e8b7a9
Version: 3
Effective Time: 20230217
 
Kareway Product, Inc.