CAPSAICIN HOT PATCHES- capsaicin patch

CAPSAICIN HOT PATCHES by

Drug Labeling and Warnings

CAPSAICIN HOT PATCHES by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, 110 dba LEADER, 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 associated with: arthritis, minor backache, muscle strains,
muschle sprains, bruises

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

TOLL-FREE

Customer Care Help Line
866-326-1313

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

Made in China

LABEL

INGREDIENTS AND APPEARANCE

CAPSAICIN HOT PATCHES 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0556
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: 70000-0556-1	2 in 1 BOX	06/01/2020
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 - Cardinal Health, 110 dba LEADER (063997360)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(70000-0556)