Otc - Active Ingredient
Drug Facts
Active ingredient Purpose
Capsicum extract 0.025% as Capsaicin. ........... Topical analgesic
Cvs Medicated Heat Patch
FDA Label NDC 51316-119
12 label sections · Submitted to the FDA by Cvs Pharmacy · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Medicated Heat Patch (NDC 51316-119). 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 otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
temporary relief of minor aches and pains of muscles and joints
associated with: arthritis simple backache sprains
bruises strains
Warnings
Warnings
For external use only.
Allergy alert: do not use if you are allergic to natural rubber,
capsicum, chili peppers, or any ingredients in this product.
Otc - Do Not Use
Do not use
on wounds or damaged skin with a heating pad
Otc - When Using
When using this product
use only as directed
avoid contact with the eyes
do not bandage tightly
discontinue use at least 1 hour before a bath or shower
do not use immediately after a bath or shower
Otc - Stop Use
Stop use and ask a doctor if
condition worsens, symptoms persist for more than 7 days, or
clear up and occur again within a few days
redness is present or irritation or rash develops
a severe burning sensation occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center (1-800-222-1222) right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before
use.
Indications & Usage
Directions
adults and children 12 years of age and older:
clean and dry affected area
remove patch from film
apply to affected area no more than 3 to 4 times daily
do not wear patch for more than 8 hours
children under 12 years of age: consult a doctor
Storage And Handling
Other information
avoid storing product in direct sunlight
protect product from excessive moisture
keep outer carton for complete warnings and product
information (Inner Labeling w/Carton)
tamper evident: do not use if carton is open or pouch looks
damaged or broken (Inner Labeling w/Carton)
Inactive Ingredient
Inactive ingredients butylated hydroxytoluene,
diphenhydramine hydrochloride, glyceryl rosinate, lanolin, natural
rubber, petrolatum, polyisobutylene (85000 MW),
styrene-isoprene-styrene block copolymer, titanium dioxide, zinc
oxide
Dosage & Administration
Questions or comments?
Call 1-888-645-8204 Monday-Friday 9AM-5PM (PST)
*This product is not manufactured or distributed by Hisamitsu
America Inc., a subsidiary of Hisamitsu Pharmaceutical Co., Inc.
distributor of Salonpas Hot Capsicum Patch.
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
2027 CVS/pharmacy
CVS.com 1-800-SHOP CVS
Made in China
V-33754
938866-ZDP-PH-R1
PR-TP-ZDP201-R1
* Please review the disclaimer below.
