COLD AND HOT 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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Drug Facts

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • muscle strains
  • simple backache
  • bursitis
  • cramps
  • tendonitis
  • muscle sprains
  • bruises

Warnings

For external use only

When using this product

  • use only as directed
  • do not bandage tightly
  • do not 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:

  • Remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
  • Carefully remove backing from patch
  • Apply one patch to affected area
  • Repeat as necessary, but no more than 4 times daily

Children under 12 years of age: Ask a doctor

Other information

store at room temperature

Inactive ingredients

aluminium glycinate, 1,3-butylene glycol, carboxymethylcellulose sodium, concentrated glycerin, diethylene glycol monoethyl ether, disodium edetate, methyl parahydroxybenzoate, polyacrylic acid solution, polysorbate 80, propyl parahydroxybenzoate, purified water, tartaric acid, titanium dioxide

package label

Cold and Hot Pain Relief Patch image of carton label

COLD AND HOT PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL400 mg
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0030-21 in 1 CARTON09/12/2011
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:67510-0030-41 in 1 CARTON09/12/2011
24 in 1 POUCH; Type 0: Not a Combination Product
3NDC:67510-0030-31 in 1 CARTON09/12/2011
33 in 1 POUCH; Type 0: Not a Combination Product
4NDC:67510-0030-51 in 1 CARTON09/12/2016
45 in 1 POUCH; Type 0: Not a Combination Product
5NDC:67510-0030-61 in 1 CARTON09/12/2016
56 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/12/201112/01/2022
Labeler - Kareway Product, Inc. (121840057)

Revised: 12/2022
Document Id: f115f20d-a98d-68f6-e053-2a95a90aa0f3
Set id: 46345292-2a99-4278-8693-7e4a4097d14f
Version: 6
Effective Time: 20221230
 
Kareway Product, Inc.