Search by Drug Name or NDC

NDC 71101-0904-02 2-Count HEAT PATCHES 0.25 g/g Details

2-Count HEAT PATCHES 0.25 g/g

2-Count HEAT PATCHES is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Veridian Healthcare. 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: 71101-0904-02
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Capsaicin Transdermal Patch

Product Information

NDC	71101-0904
Product ID	71101-904_bbce193c-fc1c-42ce-8399-66b2fede7f5e
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	0.25
Active Ingredient Units	g/g
Substance Name	CAPSAICIN
Labeler Name	Veridian Healthcare
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 71101-0904-02 (71101090402)

Pricing Information	N/A
NDC Package Code	71101-904-02
Billing NDC	71101090402
Package	2 PATCH in 1 BOX (71101-904-02) / 9 g in 1 PATCH
Marketing Start Date	2018-11-21
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 81295195-2339-4d5b-b192-39730debadf8 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

TOLL-FREE

Customer Care Help Line

866-326-1313

Mon-Fri 8:30 am - 4:30 pm CST

LABEL

Manufactured For:

Veridian Healthcare, LLC

1175 Lakeside Drive

Gurnee, IL 60031 USA

Made in China

INGREDIENTS AND APPEARANCE

2-COUNT HEAT PATCHES

capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71101-904
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 g in 1 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:71101-904-02	2 in 1 BOX	11/21/2018
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	11/21/2018

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(71101-904)

Revised: 11/2018

Document Id: bbce193c-fc1c-42ce-8399-66b2fede7f5e

Set id: 81295195-2339-4d5b-b192-39730debadf8

Version: 6

Effective Time: 20181121