CAPSAICIN PAIN RELIEF- capsaicin 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 Capsaicin Pain Relief Patch

Active ingredient

Capsicum extract 0.025% as Capsaicin

Purpose

Topical analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

Warnings

For external use only.

Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower.

Do not use

  • on wounds or damaged skin
  • with a heating pad
  • with, or at the same times as other external analgesic products
  • if you are allergic to any ingredients of this product

When using this product

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes

Stop use and ask a doctor if

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

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 over:

Children under 12 years of age:


Other information

Inactive ingredients

hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

Package label

Capsaicin Hot Patch

label

CAPSAICIN PAIN RELIEF 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.702 mg
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0303-11 in 1 CARTON01/23/2012
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:67510-0303-22 in 1 POUCH; Type 0: Not a Combination Product05/18/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/23/2012
Labeler - Kareway Product, Inc. (121840057)

Revised: 6/2018
Document Id: 6e120fc6-2435-8dae-e053-2a91aa0a8f89
Set id: dce9db37-cd07-44d8-8881-f63a2191964f
Version: 3
Effective Time: 20180607
 
Kareway Product, Inc.