Label: PAINBLOC- capsaicin 0.25% liquid
- NDC Code(s): 0295-9029-60
- Packager: Denison Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 9, 2020
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- Active Ingredient
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
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
- PRINCIPAL DISPLAY PANEL - 12 mL Bottle Carton
INGREDIENTS AND APPEARANCE
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)