2-COUNT HEAT PATCHES- capsaicin patch

2-Count HEAT PATCHES by

Drug Labeling and Warnings

2-Count HEAT PATCHES by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association), Foshan Aqua Gel Biotech Co.,Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

2-COUNT HEAT PATCHES 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-308
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
LIQUID PETROLEUM (UNII: 6ZAE7X688J)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-308-02	2 in 1 BOX	06/01/2017
1		9 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2017

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(63868-308)