PAINBLOC- capsaicin 0.25% liquid

PainBloc by

Drug Labeling and Warnings

PainBloc by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

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

Questions

Call 855-438-3944

PRINCIPAL DISPLAY PANEL - 12 mL Bottle Carton

INGREDIENTS AND APPEARANCE

PAINBLOC 
capsaicin 0.25% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9029
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9029-60	1 in 1 CARTON	03/09/2020
1		12 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/09/2020

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-9029)