Active Ingredient
Capsaicin (Nonivamide) 0.19%
Nufabrx Medicine Infused Ankle Sleeve Cloth
FDA Label NDC 72490-039
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nufabrx Llc for the product Nufabrx Medicine Infused Ankle Sleeve (NDC 72490-039). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding, keep out of reach children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
