NUFABRX CALF SLEEVE- capsaicin cloth

Nufabrx Calf Sleeve by

Drug Labeling and Warnings

Nufabrx Calf 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) 0.16%

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 ingredents of this product o chili peppers, contact a doctor before use (allergy alert)
• On wounds or damages skin
• With, or at the 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 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 irriation develops

If pregnant or breast feeding

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 packagin and place on calf
• Maximum use of 10 hours per day
• 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

Acrylate copolymer

Entire Label

INGREDIENTS AND APPEARANCE

NUFABRX CALF SLEEVE 
capsaicin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72490-019
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.16 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: 72490-019-10	1 g in 1 BOX; Type 0: Not a Combination Product	03/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	03/15/2021

Labeler - Nufabrx LLC (119110776)

Registrant - Nufabrx LLC (119110776)