NUFABRX MEDICINE INFUSED ANKLE SLEEVE- capsaicin cloth

Nufabrx Medicine Infused Ankle Sleeve by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

Capsaicin (Nonivamide) 0.19%

Purpose

Topical Analgesic

Uses

Temporary relieves minor pain associated with:

• arthritis
• ankle pain
• muscle strains
• sprains
• bruises
• cramps

Warnings

For external use only.

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 to wounds, damaged or irritated skin
• do not get into eyes or on mucous membranes
• do not use with heating pad or other external analgesic products
• a slight burning sensation may occur upon application but generally disappears in several days
• if severe burning sensation occurs, discontinue use immediately
• do not use 1 hour prior to bathing or within 30 minutes after bathing

Stop use and ask a doctor if

• conditions worsen
• severe skin irritation occurs
• pain persists for more than 7 days
• symptoms clear up and occur again within a few days

If pregnant or breast-feeding

Ask a health professional before use.

Keep out of reach 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 ankle
• maximum use of 10 hours per day

Product care instructions

• wash separately from other clothes
• do not store in direct sublight
• protect product from excessive moisture when not in use

Inactive ingredient

acrylate copolymer

Label

INGREDIENTS AND APPEARANCE

NUFABRX MEDICINE INFUSED ANKLE SLEEVE 
capsaicin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72490-039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.19 g  in 100 g

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

Product Characteristics
Color	black	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72490-039-10	1 g in 1 BOX; Type 0: Not a Combination Product	07/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	07/19/2023

Labeler - Nufabrx LLC (119110776)

Registrant - Nufabrx LLC (119110776)

Establishment
Name	Address	ID/FEI	Business Operations
Textile-Based Delivery Inc		079309716	api manufacture(72490-039)