Otc - Active Ingredient
Methyl salicylate
Vanillyl nonylamide
Hot Pap Cataplasma Patch
FDA Label NDC 87538-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Masaem Company for the product Hot Pap Cataplasma (NDC 87538-0001). 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, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Kaolin
Glycerin
Liquid paraffin
Gelatin
Titanium oxide
Carboxymethylcellulose sodium
Zinc oxide
Methoxyethylene maleicanhydride copolymer
Polybutene
Citric acid hydrate
Sodium polyacrylate
Thymol
Butyl paraben
Butylated hydroxy toluene
Polysorbate 60
Isopropyl myristate
Natural rubber latex
Purified water
Nonwoven fabric
Polyester film
Otc - Purpose
Topical Analgesic
Temporarily relieves minor pain associated with - muscular pain - joint pain - backache - bruise - sprain
Otc - Keep Out Of Reach Of Children
keep out of reach of the children
Indications & Usage
Adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily.
Children under 12 years of age: do not use, consult a doctor
For easy application: partially peel back protective film and apply exposed patch to the site of pain.
Carefully remove remaining film while pressing patch to skin for secure adhesion.
Warnings
use only as directed
do not bandage tightly or use with a healing pad
avoid contact with the eyes and mucous membranes
do not apply to wounds or damaged skin
Dosage & Administration
for external use only
* Please review the disclaimer below.
