Nufabrx Compression Sock

Drug Labeling and Warnings

Drug Details [pdf]

NUFABRX COMPRESSION SOCK- capsaicin cloth 
Textile-Based Delivery, Inc.

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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Nufabrx Compression Sock

Active Ingredient

Nonivamide (synthetic capsaicin) 0.075%

Purpose

Topical Analgesic

Uses

  • For simple foot pain, arthritis & strains
  • Use on bruises & sprains

Warnings

For external use only

Do not use

  • On wounds or to damaged skin
  • With, or at same time as, other analgesic products
  • Allergy Alert: if you are allergic to any ingredients of this product or chili peppers contact a doctor before use
  • If pregnant or breastfeeding consult a healthcare professional before use

When using this product

  • You may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally diminishes.
  • Do not use immediately before or after activities such as swimming, showering, sunbathing or intense exercise.
  • Use only as directed
  • Avoid contact with eyes and mucous membranes or rashes

Ask a doctor before use if

  • your condition worsens, symptoms persist more than 7 days or clear up and occur again within a few days
  • rash, itching or excessive skin irritation develops

Keep out of reach of children.

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

Directions

  • Clean and dry affected area
  • Remove sock from packaging and place on feet
  • Remove sock after 8 hours of wear
  • Wear sock daily, but not more than 4 times per week

Other Information

Avoid storing product in direct sunlight. Protect product from excessive moisture

Inactive Ingredients

WS-23 (synthetic cooling agent)

Principal Display Panel

sockPDP

sockDF

NUFABRX COMPRESSION SOCK 
capsaicin cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72490-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.075 
Inactive Ingredients
Ingredient NameStrength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72490-004-012 in 1 POUCH; Type 0: Not a Combination Product01/14/2019
2NDC: 72490-004-022 in 1 POUCH; Type 0: Not a Combination Product01/14/2019
3NDC: 72490-004-032 in 1 POUCH; Type 0: Not a Combination Product01/14/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/14/201901/14/2019
Labeler - Textile-Based Delivery, Inc. (079309716)

Revised: 8/2019
Document Id: 90cda10a-d624-db5e-e053-2995a90ac8e4
Set id: 7fc2bf51-be32-cd1d-e053-2991aa0af519
Version: 3
Effective Time: 20190823