Country: United States
Language: English
Source: NLM (National Library of Medicine)
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)
Textile-Based Delivery, Inc.
TOPICAL
OTC DRUG
Topical Analgesic For the temporary relief of minor aches and pains of muscles and joints associated with: - simple backache - arthritis - strains - bruises - sprains
OTC monograph not final
KENTWOOL SENSATIONWOOL WITH NUFABRX- 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._ ---------- KENTWOOL SENSATIONWOOL WITH NUFABRX ACTIVE INGREDIENT Capsaicin (Nonivamide) 0.036% PURPOS E Topical Analgesic US ES For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains WARNINGS FOR EXTERNAL USE ONLY DO NOT USE ALLERGY ALERT: if you are allergic to any ingredient of this product or chili peppers contact a doctor before use On wounds or to damaged skin With, or at same time as, other 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 A 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 sock from packaging and place on feet Maximum use of 8 hours per day. Remove sock after 8 hours of wear Wash separately from other clothing Wear sock daily, but not more than 4 times per week OTHER INFORMATION Avoid storing product in direct sunlight. Protect product from excessive moisture INACTIVE INGREDIENTS Wool PRINCIPAL DISPLAY PANEL KENTWOOL SENSATIONWOOL WITH NUFABRX capsaicin cloth PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) Read the complete document