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2-Count HEAT PATCHES by QUALITY CHOICE (Chain Drug Marketing Association)

Medically reviewed on June 14, 2017

Dosage form: patch
Ingredients: CAPSAICIN 0.025g in 100g
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
NDC Code: 63868-308

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.

HEAT PATCH

For External Use Only
  • Discontinue use at least one hour prior to bath / shower / swimming; do not use immediatelty after bath / shower / swimming.
  • Allergy alert: if you are allergic or suspect you are allergic to the ingredients listed below, including chili perppers.. consults with your physician before use.

Uses

Temporary relief of minor pain associated with:

  • Arthiritis
  • Minor backache
  • Strains
  • Sprains
  • Bruises

Purpose

Temporary relief of minor pain.

Active Ingredients

 Capsaicin: 0.025%...........................Topical Analgesic

Inactive Ingredients:

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Directions for Use:

For Use on Adults and Childrens 12 Years of Age or Older

  • Clean and dru affected area; ensure area is fully dry before application
  • Remove patch from film
  • Apply to treatement site
  • Patch may be trimmerd to best fit treatment site; trim patch before removing film
  • Wash hands after application
  • Discard after signle use
Caution:
  • Take care when using on elderly ot incapacited persons
  • Do not use more than 8 hours
  • Do not use the Capsaicin Heat Patch more than 3-4 times daily
  • Do not exceed 7 days of continue use

Keep Out of Reach of Children

if swallowed, contacr a poison control center immediately.

Storage and Care:
  • One time use only; do not attempt to reuse the product
  • avoid storage in direct sunlight
  • Protect patch from excessive moisture

Do Not Use:
  • On areas with sensitive skin, open wounds or previous burns
  • with pain rubs, medicated lotions, creams or oinments
  • with other forms of heat theraphy, including heating pads, or multiples of this treatment on a single treatement site

Use Only as Directed:
  • Follow the below directions for use.
  • Avoid contact with eyes, mucus membrances or skin rashes.

Stop Use immediately and Seek Medical Attention if:
  • Rash, itching or excessive skin irritation develops
  • Conditions worsens
  • Symptons persist more than 7 days
  • Symptoms clear, and reoccur within a few days

QUESTIONS

Customer Care Help Line
248-449-9300
www.qualitychoice.com

LABEL

Distributed by C.D.M.A., Inc.

43157 W. Nine Mile

Novi, MI 48375

Made in China

2-COUNT HEAT PATCHES 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-308
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED POLYDECENE (550 MW) 
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) 
LIQUID PETROLEUM 
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) 
Product Characteristics
Color    Score    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-308-022 PATCH in 1 BOX
19 g in 1 PATCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2017
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
Establishment
NameAddressID/FEIOperations
Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(63868-308)

 
QUALITY CHOICE (Chain Drug Marketing Association)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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