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NDC 11822-4210-03 CAPSAICIN HEAT PATCHES PAIN RELIEF 0.025 g/100g Details

CAPSAICIN HEAT PATCHES PAIN RELIEF 0.025 g/100g

CAPSAICIN HEAT PATCHES PAIN RELIEF is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by Rite Aid. 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: 11822-4210-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Capsaicin Transdermal Patch

Product Information

NDC	11822-4210
Product ID	11822-4210_e5819a56-e06e-cac9-e053-2995a90ac3ce
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	CAPSAICIN HEAT PATCHES PAIN RELIEF
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	Rite Aid
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 11822-4210-03 (11822421003)

Pricing Information	N/A
NDC Package Code	11822-4210-3
Billing NDC	11822421003
Package	3 PATCH in 1 BOX (11822-4210-3) / 9 g in 1 PATCH
Marketing Start Date	2022-08-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e5819a56-e06d-cac9-e053-2995a90ac3ce Details

Active Ingredients

Capsaicin: 0.025%...........................Topical Analgesic

Purpose

Topical Analgesic

Uses

Temporary relief of minor pain of muscles and joints associated with:

Arthiritis
Minor backache
Strains
Sprains
Bruises

Warnings

For External Use Only

Allergy alert

If you are allergic or suspect you are allergic to the ingredients of this product, including chill peppers, consult with your physician before use.

Do Not Use:

On wounds or damaged skin
with pain rubs, medicated lotions, creams, or ointments
with heating pads

When Using this product

Use only as directed
Avoid contact with eyes, mucous membranes or rashes
do not bandage tightly
discontinue use at least 1 hour before a bath or shower
do not use immediately after a bath or shower
do not microwave
dispose of used patch in a manner that always keeps products away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingest this patch.

Stop Use and ask a doctor if:

Skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
Conditions worsens
Symptoms persist more than 7 days
Symptoms clear, and reoccur within a few days

If pregnant or breast-feeding

Ask a health professional before use

Keep Out of Reach of Children

if swallowed, contact a poison control center (1-800-222-1222) immediately.

Inactive Ingredients:

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Directions:

Adults and Children 12 Years of Age and over:

Clean and dry affected area
Remove patch from film
Apply to affected area not more than 3 to 4 times daily
use one patch for up to 8 hours
Discard after single use
Children under 12 years of age: consult a physician

Other Information

Avoid storage in direct sunlight
Protect patch from excessive moisture

Inactive Ingredients

hydrogenated C6-20 polyolefin, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

QUESTIONS

866-326-1313 Monday - Friday 8:30 am -4:30 pm CST

LABEL

INGREDIENTS AND APPEARANCE

CAPSAICIN HEAT PATCHES PAIN RELIEF

capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-4210
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
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
LIQUID PETROLEUM (UNII: 6ZAE7X688J)
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV)
HYDROGENATED C6-20 POLYOLEFIN (100 CST) (UNII: 39EYQ1W9RB)

Product Characteristics
Color		Score
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:11822-4210-3	3 in 1 BOX	08/01/2022
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	08/01/2022

Labeler - Rite Aid (014578892)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Aqua Gel Biotech Co.,Ltd.		529128763	manufacture(11822-4210)

Revised: 8/2022

Document Id: e5819a56-e06e-cac9-e053-2995a90ac3ce

Set id: e5819a56-e06d-cac9-e053-2995a90ac3ce

Version: 1

Effective Time: 20220805