PainBloc by Denison Pharmaceuticals, LLC PainBloc

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]

PAINBLOC- capsaicin 0.25% liquid 
Denison Pharmaceuticals, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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PainBloc

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 apply immediately before or after exercising, swimming, bathing, showering or exposure to heat or sunlight
• Do not expose the area treated with product to heat or direct sunlight
• If using before exercise, showering or swimming, apply, wait 30-60 minutes, then wash off with soap and cold water 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 a single layer to the affected area. A little goes a long way, so apply using single strokes until the area is covered.
• Allow to dry
• Wash hands with soap and cold water after each application
• Wash application site 30-60 minutes after applying. This will reduce the risk of transferring medicine to sensitive areas
• repeat application as needed, every 12 to 24 hours
• Do not use more than twice a day
• Relief builds and may take several days to reach full effect

Inactive Ingredients

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

Questions

Call 855-438-3944

PRINCIPAL DISPLAY PANEL - 12 mL Bottle Carton

PAINBLOC 
capsaicin 0.25% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-9034
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
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-9034-02	1 in 1 CARTON	12/02/2020
1		14 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
2	NDC: 0295-9034-63	1 in 1 CARTON	12/02/2020
2		22 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	12/02/2020

Labeler - Denison Pharmaceuticals, LLC (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC		001207208	manufacture(0295-9034)

Revised: 12/2020

Document Id: b57d0e22-2c2e-099d-e053-2a95a90ab309

34390-5

Set id: b57d0cfc-1592-c14a-e053-2995a90a6286

Version: 1

Effective Time: 20201202