Active Ingredient
Capsaicin 0.25%
Painbloc24
FDA Label NDC 71226-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vizuri Health Sciences Llc for the product Painbloc24 (NDC 71226-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a healthcare professional before use.
Otc - Keep Out Of Reach Of Children
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 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
Questions
Call 855-438-3944
Other
Distributed by Vizuri Consumer Healthcare
Fairfax, VA 22033 U.S.A.
Principal Display Panel - 12 Ml Bottle Carton
L (Label)
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