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

Purpose

Topical Analgesic

Description

Capsaicin 0.25%


Medication Information

Warnings

For external use only

Uses

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

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

Topical Analgesic

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
Inactive Ingredients

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

Description

Capsaicin 0.25%

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.

Questions

Call 855-438-3944

Active Ingredient

Capsaicin 0.25%

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

Warnings

For external use only

Uses

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

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

Topical Analgesic

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
Inactive Ingredients

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

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.

Questions

Call 855-438-3944

Active Ingredient

Capsaicin 0.25%

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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