Active Ingredient

Capsaicin (Nonivamide) 0.19%

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 or chili peppers, contact a doctor before use (allergy alert)
On wounds or damaged 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 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 lower leg
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

Princial Display and Drug Facts

Front Label Back Label 72490-022 Back Label 72490-023 Back Label 72490-024

NUFABRX LOWER LEG SLEEVE XL/XXL
capsaicin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72490-024
Route of Administration	TOPICAL

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

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

Product Characteristics
Color	black (Size XL/XXL)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72490-024-11	1 g in 1 POUCH; Type 0: Not a Combination Product	03/26/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	03/26/2021

NUFABRX LOWER LEG SLEEVE M/L
capsaicin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72490-023
Route of Administration	TOPICAL

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

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

Product Characteristics
Color	black (Size M/L)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72490-023-11	1 g in 1 POUCH; Type 0: Not a Combination Product	03/26/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	03/26/2021

NUFABRX LOWER LEG SLEEVE XS/S
capsaicin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72490-022
Route of Administration	TOPICAL

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

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

Product Characteristics
Color	black (Size XS/S)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72490-022-11	1 g in 1 POUCH; Type 0: Not a Combination Product	03/26/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	03/26/2021

Labeler - Nufabrx LLC (119110776)

Registrant - Biotech Research Group (099152813)

Nufabrx Lower Leg Sleeves