NUFABRX MEDICINE INFUSED SOCKS- 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 S/M Socks

Active ingredient

Capsaicin (Nonivamide) 0.11%

Purpose

Topical Analgesic

Uses

Temporary relieves minor pain associated with:

arthritis
foot, ankle, and calf 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 socks from packaging, pull up over calf until snug
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

Entire Label

NUFABRX MEDICINE INFUSED SOCKS
capsaicin cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72490-036
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.11 g in 100 g

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

Product Characteristics
Color	black	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72490-036-10	1 g in 1 POUCH; Type 0: Not a Combination Product	07/19/2023

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

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

Registrant - Biotech Research Group (099152813)

Revised: 7/2023

Document Id: 013cd34b-243f-c2e0-e063-6394a90a87d6

Set id: 00d7d5bf-ee03-e73d-e063-6394a90a5d94

Version: 2

Effective Time: 20230724

Textile-Based Delivery, Inc.