HOT PAP CATAPLASMA- methyl salicylate, vanillyl nonylamide patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Lydia Co., Ltd.
Administration route:
TRANSDERMAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Analgesic Temporarily relieves minor pain associated with - muscular pain - joint pain - backache - bruise - sprain 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.
Authorization status:
OTC monograph not final
Authorization number:
72988-0007-1

HOT PAP CATAPLASMA- methyl salicylate, vanillyl nonylamide patch

Lydia Co., Ltd.

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.

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Drug Facts

Methyl salicylate

Vanillyl nonylamide

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

Topical Analgesic

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

keep out of reach of the children

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.

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

for external use only

HOT PAP CATAPLASMA

methyl salicylate, vanillyl nonylamide patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:729 8 8 -0 0 0 7

Route of Administration

TRANSDERMAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

58 .3 mg in 13.4 g

Inactive Ingredients

Ingredient Name

Stre ng th

THYMO L (UNII: 3J50 XA376 E)

KAO LIN (UNII: 24H4NWX5CO)

GLYCERIN (UNII: PDC6 A3C0 OX)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:729 8 8 -0 0 0 7-1

13.4 g in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct

0 3/29 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 3/29 /20 19

Labeler -

Lydia Co., Ltd. (695735569)

Registrant -

Lydia Co., Ltd. (695735569)

Lydia Co., Ltd.

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Jeil Health Science Inc.

6 8 9 8 51513

ma nufa c ture (729 8 8 -0 0 0 7)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Lydia Co ., Ltd.

6 9 573556 9

la be l(729 8 8 -0 0 0 7)

Revised: 3/2019

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