Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 85360782-69cc-ba9e-e053-2a91aa0a5431
Route
TRANSDERMAL
Published
Effective Date 2019-03-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (58.3 mg) Nonivamide (5 mg)
Inactive Ingredients
Thymol Kaolin Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2019-03-29

Description

Methyl salicylate Vanillyl nonylamide


Medication Information

Warnings and Precautions

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

Indications and 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.

Dosage and Administration

for external use only

Description

Methyl salicylate Vanillyl nonylamide

Section 50565-1

keep out of reach of the children

Section 51727-6

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

Section 51945-4

Section 55105-1

Topical Analgesic

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

Section 55106-9

Methyl salicylate

Vanillyl nonylamide


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

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

Section 55106-9 (55106-9)

Methyl salicylate

Vanillyl nonylamide


Advanced Ingredient Data


Raw Label Data

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