The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Medicated Pain Relieving Patch 60ct (NDC 36800-750). 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, other safety information, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients Purpose
Camphor 3.1%............................................................Topical analgesic
Menthol 6.0%..............................................................Topical analgesic
Methyl salicylate 10.0%...............................................Topical analgesic
Uses
temporary relief of minor aches and pains of muscles and joints
associated with:
arthritis simple backache sprains bruises
strains
Warnings
For external use only.
Do not use
on wounds or damaged skin with a heating pad
if you are allergic to any ingredients of this product
on a child under 12 years of age with arthritis-like conditions
Allergy alert: If prone to allergic reaction from aspirin or salicylates,
consult a doctor before use.
When using this product
use only as directed
avoid contact with the eyes, or mucous membranes
do not bandage tightly
discontinue use at least 1 hour before a bath or shower
do not use immediately after a bath or shower
Stop use and ask a doctor if
condition worsens, or 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
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or
contact a Poison Control Center (1-800-222-1222) right away.
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 4 hours
children under 12 years of age: consult a doctor
Other information
store at room temperature 20-25°C (68-77°)
avoid storing product in direct sunlight
protect product from excessive moisture
Inactive ingredients aluminum silicate, butylated
hydroxytoluene, glyceryl rosinate, lanolin, natural rubber, paraffin,
polyisobutylene (85000 MW), polyisobutylene (800000 MW),
styrene-isoprene-styrene block copolymer, titanium dioxide, zinc oxide
Questions or comments?
Call 1-888-423-0139
Distributed By TOPCO ASSOCIATES LLC
ITASCA, IL 60143 @TOPCO UNXA0525
Questions? 1-888-423-0139
[email protected] www.topcarebrand.com
MADE IN CHINA
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