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:

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:

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

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PAINBLOC 
capsaicin 0.25% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-9029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-9029-601 in 1 CARTON03/09/2020
112 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/09/2020
Labeler - Denison Pharmaceuticals, LLC (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208manufacture(0295-9029)

Revised: 3/2020
Document Id: a06dc54e-250a-7036-e053-2995a90a5603
Set id: a06dc1dc-7646-e2b8-e053-2a95a90a9268
Version: 1
Effective Time: 20200309
 
Denison Pharmaceuticals, LLC