HOT PAP CATAPLASMA- methyl salicylate, vanillyl nonylamide patch

Hot Pap Cataplasma by

Drug Labeling and Warnings

Hot Pap Cataplasma by is a Otc medication manufactured, distributed, or labeled by Lydia Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Methyl salicylate

Vanillyl nonylamide

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

PURPOSE

Topical Analgesic

Temporarily relieves minor pain associated with - muscular pain - joint pain - backache - bruise - sprain

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HOT PAP CATAPLASMA 
methyl salicylate, vanillyl nonylamide patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72988-0007
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	58.3 mg  in 13.4 g

Inactive Ingredients
Ingredient Name	Strength
THYMOL (UNII: 3J50XA376E)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72988-0007-1	13.4 g in 1 POUCH; Type 0: Not a Combination Product	03/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/29/2019

Labeler - Lydia Co., Ltd. (695735569)

Registrant - Lydia Co., Ltd. (695735569)

Establishment
Name	Address	ID/FEI	Business Operations
Jeil Health Science Inc.		689851513	manufacture(72988-0007)

Establishment
Name	Address	ID/FEI	Business Operations
Lydia Co., Ltd.		695735569	label(72988-0007)