Nufabrx Grey Polka Dot Sock

Nufabrx Grey Polka Dot Sock by

Drug Labeling and Warnings

Nufabrx Grey Polka Dot Sock by is a Otc medication manufactured, distributed, or labeled by Textile-Based Delivery, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NUFABRX GREY POLKA DOT 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 Grey Polka Dot Sock

Active Ingredient

Synthetic Capsaicin 0.18%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, and sprains.

Warnings

For external use only

Do not use

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

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, or sunbathing.
  • Use only as directed.
  • Avoid contact with eyes and mucous membranes or rashes.
  • Wash hands after putting product on body and before touching your face or eyes.

Stop use and ask a doctor if

  • 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
  • If pregnant or breastfeeding consult 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

  • Clean and dry affected area
  • Remove poducct on put on body
  • Maximum use of 8 hours per day
  • Do not wear more than 4 days per week without doctor consent
  • Wash separately for best results

Other Information

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

Inactive Ingredients

Acrylates Copolymer

Principal Display Panel

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NUFABRX GREY POLKA DOT SOCK 
capsaicin cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72490-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.18 
Inactive Ingredients
Ingredient NameStrength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72490-015-012 in 1 POUCH; Type 0: Not a Combination Product05/18/2020
2NDC: 72490-015-022 in 1 POUCH; Type 0: Not a Combination Product05/18/2020
3NDC: 72490-015-032 in 1 POUCH; Type 0: Not a Combination Product05/18/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/18/202010/20/2021
Labeler - Textile-Based Delivery, Inc. (079309716)

Revised: 10/2021
Document Id: cecca646-64e8-10b3-e053-2a95a90a8647
Set id: a7219e85-e205-55f8-e053-2a95a90a45c9
Version: 2
Effective Time: 20211020