PainBloc24

Manufacturer
Vizuri Health Sciences LLC
Effective date
2022-01-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:46:18

Label at a glance#

ProductPainBloc24
Active ingredientCAPSAICIN
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints associated with: Arthritis Simple backache Muscle strains Bruises Sprains

Dosage and administration

Adults over 18 years: Apply by holding Pain Pen straight down and press tip repeatedly on to affected area until liquid flows. Then dab sparingly. Allow to dry Repeat application, as needed, every 12 to 24 hours Do not use more than twice a day Wash hands with soap and water after each application. If applying to hand, wait 30minutes, then wash with soap and cold water after each application. If soap does not comp...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.25%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • Arthritis
  • Simple backache
  • Muscle strains
  • Bruises
  • Sprains

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults over 18 years:

  • Apply by holding Pain Pen straight down and press tip repeatedly on to affected area until liquid flows. Then dab sparingly.
  • Allow to dry
  • Repeat application, as needed, every 12 to 24 hours
  • Do not use more than twice a day
  • Wash hands with soap and water after each application. If applying to hand, wait 30minutes, then wash with soap and cold water after each application.
  • If soap does not completely remove all product residues, try using skin or mineral oil.
  • May take several days to reach full effect

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions

OTC - QUESTIONS SECTION

Call 855-438-3944

SPL UNCLASSIFIED SECTION

Distributed by Vizuri Consumer Healthcare
Fairfax, VA 22033 U.S.A.

PRINCIPAL DISPLAY PANEL - 12 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ll

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1874747capsaicin 0.25 % Topical SolutionPSN3
1874747capsaicin 2.5 MG/ML Topical SolutionSCD3
1874747capsaicin 0.25 % Topical SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71226-001-062024-01-30C16284748780-11030e365-53da-111a-e063-dadaa90a10e2PainBloc24

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71226-001-06PainBloc241 in 1 CARTONSOLUTION13
71226-001-06PainBloc2412 mL in 1 BOTTLE, WITH APPLICATORSOLUTION123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71226-001PAINBLOC24 (CAPSAICIN 0.25%) SOLUTION [VIZURI HEALTH SCIENCES LLC]3Legacy NDC, 2 package rows20220105_969aa707-0e6c-db5f-e053-2995a90a840a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71226-00171226-001-06

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d4c1f183-39e7-6be3-e053-2995a90aedf1969aa707-0e6c-db5f-e053-2995a90a840a2022-01-04WarningsExact identifier
spl id: d4c1f183-39e7-6be3-e053-2995a90aedf1
spl set id: 969aa707-0e6c-db5f-e053-2995a90a840a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.