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NDC 63868-0308-02 2-Count HEAT PATCHES 0.025 g/100g Details

2-Count HEAT PATCHES 0.025 g/100g

2-Count HEAT PATCHES is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). The primary component is CAPSAICIN.

MedlinePlus Drug Summary

Nonprescription (over-the-counter) capsaicin patches (Aspercreme Warming, Salonpas Pain Relieving Hot, others) are used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. Prescription capsaicin patches (Qutenza) are used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Prescription capsaicin patches (Qutenza) are also used to relieve the pain of diabetic neuropathy (numbness or tingling due to nerve damage in people who have diabetes). Capsaicin is a substance that is found in chili peppers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.

Related Packages: 63868-0308-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Capsaicin Transdermal Patch

Product Information

NDC	63868-0308
Product ID	63868-308_c9351a5f-6cc8-4b47-9aa3-5e0cab0b67a0
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	2-Count HEAT PATCHES
Proprietary Name Suffix	n/a
Non-Proprietary Name	CAPSAICIN
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	0.025
Active Ingredient Units	g/100g
Substance Name	CAPSAICIN
Labeler Name	QUALITY CHOICE (Chain Drug Marketing Association)
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0308-02 (63868030802)

Pricing Information	N/A
NDC Package Code	63868-308-02
Billing NDC	63868030802
Package	2 PATCH in 1 BOX (63868-308-02) / 9 g in 1 PATCH
Marketing Start Date	2017-06-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 722f5353-df01-4c4e-b6ce-0daa5f4a3c63 Details

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

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:63868-308-02	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 - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

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

Revised: 6/2017

Document Id: c9351a5f-6cc8-4b47-9aa3-5e0cab0b67a0

Set id: 722f5353-df01-4c4e-b6ce-0daa5f4a3c63

Version: 1

Effective Time: 20170614