NUFABRX FOOT/ANKLE SLEEVE- capsaicin cloth

Nufabrx Foot/Ankle Sleeve by

Drug Labeling and Warnings

Nufabrx Foot/Ankle Sleeve by is a Otc medication manufactured, distributed, or labeled by Textile-Based Delivery, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Capsaicin (Nonivamide) 0.12%

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

If you are allergic to any ingredients of this product or chili peppers contact a doctor before use (allergy alert)
On wounds or to damaged skin
With, or at same time as, other external 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, sunbathing or intense exercise
• Use only as directed
• Avoid contact with eyes and mucous membranes or rashes

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 sleeve from packaging and place on foot
• Maximum use of 8 hours per day (remove after 8 hours of wear)
• Wash separately from other clothing
• Do not wear more than 6 days straight without doctor consent

Other Information

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

Inactive Ingredients

Acrylates Copolymer

Principal Display Panel

INGREDIENTS AND APPEARANCE

NUFABRX FOOT/ANKLE SLEEVE 
capsaicin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72490-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.12

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72490-010-03	1 in 1 POUCH; Type 0: Not a Combination Product	05/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/11/2020

Labeler - Textile-Based Delivery, Inc. (079309716)