FDA.reportPublic FDA data

PainBloc

Manufacturer
Denison Pharmaceuticals, LLC
Effective date
2020-03-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:39:35

Label at a glance#

ProductPainBloc
Active ingredientCAPSAICIN
Label structure8 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 30 minutes, then wash with soap and cold water after each application. If soap does not com...

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 30 minutes, 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

PRINCIPAL DISPLAY PANEL - 12 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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
0295-90290295-9029-60

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
HYALURONATE SODIUMYSE9PPT4THIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5IACT
CAPSAICINS07O44R1ZMACTIB

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
ec95c41f-f7e7-c662-e053-2995a90aaa73a06dc1dc-7646-e2b8-e053-2a95a90a92682022-11-03WarningsExact identifier
spl set id: a06dc1dc-7646-e2b8-e053-2a95a90a9268

Reported adverse events (FAERS/openFDA)#

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