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NDC 71226-0001-06 PainBloc24 2.5 mg/mL Details

PainBloc24 2.5 mg/mL

PainBloc24 is a TOPICAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Vizuri Health Sciences LLC. The primary component is CAPSAICIN.

MedlinePlus Drug Summary

Topical capsaicin is used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. 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: 71226-0001-06
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Capsaicin Topical

Product Information

NDC	71226-0001
Product ID	71226-001_d4c1f445-6a08-6b8c-e053-2a95a90aa615
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	PainBloc24
Proprietary Name Suffix	n/a
Non-Proprietary Name	Capsaicin 0.25%
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	2.5
Active Ingredient Units	mg/mL
Substance Name	CAPSAICIN
Labeler Name	Vizuri Health Sciences LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71226-0001-06 (71226000106)

Pricing Information	N/A
NDC Package Code	71226-001-06
Billing NDC	71226000106
Package	1 BOTTLE, WITH APPLICATOR in 1 CARTON (71226-001-06) / 12 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date	2019-11-05
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d856dbc8-20e7-4f47-ac7b-81bb94362edc Details

SPL UNCLASSIFIED SECTION

Drug facts

Active Ingredient

Capsaicin 0.25%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with:

Arthritis
Simple backache
Muscle strains
Bruises
Sprains

Warnings

For external use only

When using this product

Use only as directed
Do not bandage tightly or cover treated area
Do not use with heating pad
Avoid contact with eyes and mucous membranes
Do not apply to wounds, damaged, broken or irritated skin
Do not expose the area treated with product to heat or direct sunlight
If using before exercise, showering or swimming, apply, wait 30 minutes, then wash off before participating
A temporary burning sensation and/or redness may occur upon application. This is normal and generally stops after a few days of use

Stop use and ask a doctor if

Severe burning sensation occurs
You experience difficulty breathing or swallowing
Condition worsens
Redness persists, spreads or becomes tender
Irritation develops
Symptoms last more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a healthcare professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults over 18 years:

Apply to affected area using roller ball until visibly moist
Allow to dry
Repeat application, as needed, every 12 to 24 hours
Do not use more than a twice a day
Wash hands with soap and water after each application
May take several days to reach full effect

Inactive Ingredients

Alcohol, Diethylene Glycol Monoethyl Ether, Hyaluronate Sodium, Polysorbate 80, Propylene Glycol, Water

Questions

Call 855-438-3944

SPL UNCLASSIFIED SECTION

Distributed by Vizuri Consumer Healthcare

Fairfax, VA 22033 U.S.A.

PRINCIPAL DISPLAY PANEL - 14 mL Bottle Carton

Vizuri

PAIN

BLOC ®

24

24 HOURS

OF ARTHRITIS PAIN RELIEF*

CAPSAICIN

Capsaicin 0.25% Topical Analgesic

MAX DOSE WITHOUT

A PRESCRIPTION
ODOR FREE

†

Arthritis

Foundation ®

Let's get a grip on arthritis.

0.5 fl oz (14 mL)

NDC:71226-001-02

PRINCIPAL DISPLAY PANEL - 14 mL Bottle Carton

INGREDIENTS AND APPEARANCE

PAINBLOC24

capsaicin 0.25% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71226-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	2.5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71226-001-01	1 in 1 CARTON	03/21/2017
1		30 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC:71226-001-02	1 in 1 CARTON	08/01/2017
2		14 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
3	NDC:71226-001-03	1 in 1 CARTON	08/01/2017
3		45 mL in 1 BOTTLE, WITH APPLICATOR; 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	03/21/2017

Labeler - Vizuri Health Sciences LLC (052129499)

Revised: 1/2022

Document Id: d4c1f445-6a08-6b8c-e053-2a95a90aa615

Set id: d856dbc8-20e7-4f47-ac7b-81bb94362edc

Version: 6

Effective Time: 20220104

Search by Drug Name or NDC

NDC 71226-0001-06 PainBloc24 2.5 mg/mL Details

PainBloc24 2.5 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71226-0001-06 (71226000106)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d856dbc8-20e7-4f47-ac7b-81bb94362edc Details

SPL UNCLASSIFIED SECTION

Active Ingredient

Purpose

Uses

Warnings

When using this product

Stop use and ask a doctor if

Directions

Inactive Ingredients

Questions

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 14 mL Bottle Carton

INGREDIENTS AND APPEARANCE

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