MEDICATED PAIN RELIEF HOT- menthol, capsicum extract 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 Hot Patch

Active ingredients

L-Menthol 0.4%

Capsicum Extract (0.002% of Capsaicin)

Purposes

Topical analgesic

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 12 years of age and older: Clean and dry affected area. Remove backing film and apply not more than 3 to 4 times daily.

Children under 12 years of age: Consult a physician.

Other information

store at 20° to 25°C (68°to 77°F)

Inactive ingredients

dihydroxyaluminum aminoacetate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, povidone, propylene glycol, propylparaben, tartaric acid, titanium dioxide, sodium polyacrylate, water

Package label

Pain Relief Hot Patch

Pain Relief Hot  Patch

MEDICATED PAIN RELIEF HOT 
menthol, capsicum extract patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL24 mg
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.12 mg
Inactive Ingredients
Ingredient NameStrength
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
POVIDONE (UNII: FZ989GH94E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0126-21 in 1 CARTON12/01/2017
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:67510-0126-41 in 1 CARTON12/01/2017
24 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2017
Labeler - Kareway Product, Inc. (121840057)

Revised: 2/2023
Document Id: f4eb549f-3dcc-7ab8-e053-2995a90a74c7
Set id: 5f52a45d-26c1-1da2-e053-2991aa0a7d49
Version: 4
Effective Time: 20230217
 
Kareway Product, Inc.