nufabrx medicine infused wrist sleeve 72490-040

nufabrx medicine infused wrist sleeve 72490-040
SPL v2
SPL
SPL Set ID 22572cf9-fc0c-d327-e063-6394a90a2186
Route
topical
Published
Effective Date 2024-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
capsaicin (0.25 g)
Inactive Ingredients
butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-09-17

Purpose

Topical Analgesic

Description

Capsaicin 0.025% to 0.25%


Medication Information

Warnings

For external use only

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • wrist pain
  • muscle strains
  • sprains
  • bruises
  • cramps
Purpose

Topical Analgesic

Directions
  • Clean and dry affected area
  • Remove sleeve from packaging and place on wrist
  • wash hands after applying
Inactive Ingredients

Acrylate Copolymer

Description

Capsaicin 0.025% to 0.25%

Principal Display Panel

Active Ingredient

Capsaicin 0.025% to 0.25%

Changes to Directions

Replaced Maximum use of 10 hours per day with wash hands after applying

When Using This Product

  • Use only as directed
  • Do not wear If you are allergic to any material in this product or chili peppers
  • Do not apply on wounds, damaged or irritated skin
  • Do not get into eyes or on mucous membranes
  • Do not use with a heating pad or other external analgesic products
  • A slight burning sensation may occur upon application in some cases
  • If severe burning sensation occurs, discontinue use immediately
Product Care Instructions
  • Machine wash cold, separately, gentle cycle, mild detergent, tumble dry low
  • do not bleach, do not iron, do not dry clean
  • Do not store in direct sunlight, protect product from excessive moisture when not in use
If Pregnant Or Breastfeeding

Ask a health professional before use.

Stop Use and Ask A Doctor If
  • Condition worsens, symptoms
  • Severe skin irriation occurs
  • Pain persists more than 7 days
  • Symptoms clear up and occur again within a few days
Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Warnings

For external use only

Uses

Temporarily relieves minor pain associated with:

  • arthritis
  • wrist pain
  • muscle strains
  • sprains
  • bruises
  • cramps
Purpose

Topical Analgesic

Directions
  • Clean and dry affected area
  • Remove sleeve from packaging and place on wrist
  • wash hands after applying
Inactive Ingredients

Acrylate Copolymer

Principal Display Panel

Active Ingredient

Capsaicin 0.025% to 0.25%

Changes to Directions

Replaced Maximum use of 10 hours per day with wash hands after applying

When Using This Product (When using this product)

  • Use only as directed
  • Do not wear If you are allergic to any material in this product or chili peppers
  • Do not apply on wounds, damaged or irritated skin
  • Do not get into eyes or on mucous membranes
  • Do not use with a heating pad or other external analgesic products
  • A slight burning sensation may occur upon application in some cases
  • If severe burning sensation occurs, discontinue use immediately
Product Care Instructions
  • Machine wash cold, separately, gentle cycle, mild detergent, tumble dry low
  • do not bleach, do not iron, do not dry clean
  • Do not store in direct sunlight, protect product from excessive moisture when not in use
If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

Ask a health professional before use.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Condition worsens, symptoms
  • Severe skin irriation occurs
  • Pain persists more than 7 days
  • Symptoms clear up and occur again within a few days
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.


Advanced Ingredient Data


Raw Label Data

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