2-Count Heat Patches (Capsaicin) Patch [Chain Drug Consortium, Llc] -

2-COUNT HEAT PATCHES (CAPSAICIN) PATCH [CHAIN DRUG CONSORTIUM, LLC]
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NDC	68016-067-02
Set ID	1a923e3b-ca0a-4a07-ba1a-76a4eb73598f
Category	HUMAN OTC DRUG LABEL
Packager	Chain Drug Consortium, LLC
Generic Name
Product Class
Product Number
Application Number	PART348

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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, contact 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

DIST. BY
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue
Wayne, PA 19087

Made in China

INGREDIENTS AND APPEARANCE

2-COUNT HEAT PATCHES
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68016-067
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68016-067-02	2 in 1 BOX	06/01/2017
1		9 g in 1 PATCH; Type 0: Not a Combination Product

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

Labeler - Chain Drug Consortium, LLC (101668460)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(68016-067)

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Medic

Use Only as Directed:

Stop Use immediately and Seek Medical Attention if: