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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Pure-Aid Cold and Hot 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
  • 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:

Children under 12 years of age: Ask a doctor

Other information

store at room temperature

Inactive ingredients

aluminium glycinate, carboxymethylcellulose, glycerin, kaolin, methylparaben, mineral oil, petrolatum, polyacrylic acid, povidone, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxide, tween 80, water

package label

Cold and Hot Pain Relief Patch

carton

COLD AND HOT PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL400 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POVIDONE (UNII: FZ989GH94E)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0300-21 in 1 CARTON02/21/2017
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:67510-0300-41 in 1 CARTON02/21/2017
24 in 1 POUCH; Type 0: Not a Combination Product
3NDC:67510-0300-31 in 1 CARTON02/21/2017
33 in 1 POUCH; Type 0: Not a Combination Product
4NDC:67510-0300-51 in 1 CARTON02/21/2017
45 in 1 POUCH; Type 0: Not a Combination Product
5NDC:67510-0300-61 in 1 CARTON02/21/2017
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 finalpart34802/21/2017
Labeler - Kareway Product, Inc. (121840057)

Revised: 2/2023
Document Id: f4ee89f0-25d6-6ffc-e053-2995a90a857b
Set id: 490f5cfb-7187-6f35-e054-00144ff8d46c
Version: 4
Effective Time: 20230217
 
Kareway Product, Inc.