Painbloc24

Painbloc24
SPL v3
SPL
SPL Set ID 969aa707-0e6c-db5f-e053-2995a90a840a
Route
TOPICAL
Published
Effective Date 2019-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (2.5 mg)
Inactive Ingredients
Alcohol Diethylene Glycol Monoethyl Ether Hyaluronate Sodium Polysorbate 80 Propylene Glycol Water Pramoxine Hydrochloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-11-05

Description

Capsaicin 0.25%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsaicin 0.25%

Uses

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

  • Arthritis
  • Simple backache
  • Muscle strains
  • Bruises
  • Sprains
Section 42229-5

Distributed by Vizuri Consumer Healthcare

Fairfax, VA 22033 U.S.A.

Section 50565-1

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

Section 53414-9

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

Warnings

For external use only

Questions

Call 855-438-3944

Directions

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
Active Ingredient

Capsaicin 0.25%

Inactive Ingredients

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

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
Principal Display Panel 12 Ml Bottle Carton


Structured Label Content

Uses

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

  • Arthritis
  • Simple backache
  • Muscle strains
  • Bruises
  • Sprains
Section 42229-5 (42229-5)

Distributed by Vizuri Consumer Healthcare

Fairfax, VA 22033 U.S.A.

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

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

Purpose

Topical Analgesic

Warnings

For external use only

Questions

Call 855-438-3944

Directions

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
Active Ingredient

Capsaicin 0.25%

Inactive Ingredients

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

When Using This Product (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 (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
Principal Display Panel 12 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 12 mL Bottle Carton)


Advanced Ingredient Data


Raw Label Data

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