SMART PRO

Manufacturer: M J Winston International Ltd.. | M J Winston International Ltd. | Sinsin Pharmaceutical Co., Ltd.
Effective date: 2011-06-20
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:28:30

Label at a glance#

ProductSMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM

Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE

Label structure9 sections

Indications and uses

for temporary relief of minor pain associated with: arthritis simple backache tendonitis muscle strains bruises

Dosage and administration

Adults and children 12 years of age and older clean and dry affected remove patch from film apply to affected area not more than 3 to 4 times daily for 7 days Children under 12 years of age consult a doctor

Storage and handling

avoid storing product in direct sunlight protect product from excessive moisture.

Contacts and useful links#

Websitewww.smartmed.us

www.smartmed.us

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

DL-Camphor 1.20 %
L-Menthol 5.70 %
Methyl Salicylate 6.30 %

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of minor pain associated with:

arthritis
simple backache
tendonitis
muscle strains
bruises

Warnings

WARNINGS SECTION

For external use only
If pregnant or breast feeding, consult a healthcare professional.
Allergy Alert: If you are allergic to any ingredients of this product, ask a doctor before use.

When using this product

OTC - WHEN USING SECTION

use only as directed
do not bandage tightly or use with heating pad
avoid contact with eyes and mucous membranes

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens
symptoms persist more than 7 days or clear up and occur again within a few days
rash, itching, excessive skin irritation develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older
clean and dry affected
remove patch from film
apply to affected area not more than 3 to 4 times daily for 7 days
Children under 12 years of age consult a doctor

Other information

STORAGE AND HANDLING SECTION

avoid storing product in direct sunlight
protect product from excessive moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylated Hydroxy Toluene, Dihydroxy Aluminum Amino Acetate, Disodium Edetate, Gelatin, Glycerin, Kaolin, Magenesium Aluminometasilicate, Methyl Paraben, Polysorbate 80, Polyvinyl Alcohol, Purified Water, Sodium Polyacrylate, Sorbitan Sesquioleate, Tartaric Acid, Titanium Dioxide

Questions or Comments?

OTC - QUESTIONS SECTION

Distributed by

M J Winston International, Ltd.

San Dimas, California 91773

www.smartmed.us

Made in Korea

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMART PRO PATCH

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2717562	camphor 1.2 % / levomenthol 5.7 % / methyl salicylate 6.3 % Medicated Patch	PSN	1
2717562	camphor 0.012 MG/MG / levomenthol 0.057 MG/MG / methyl salicylate 0.063 MG/MG Medicated Patch	SCD	1
2717562	camphor 1.2 % / levomenthol 5.7 % / methyl salicylate 6.3 % Medicated Patch	SY	1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76092-101-05	2020-01-31	C162847	48780-1	9d75b9d0-b521-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76092-101-05	SMART PROMEDICATED ANALGESIC PAIN RELIEVING CATAPLASM	5 in 1 POUCH	PATCH	5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76092-101	SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [M J WINSTON INTERNATIONAL LTD..]	1	Legacy NDC, 1 package rows	20110701_ad334d10-9053-4c40-96a5-db7236564542.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CAMPHOR (SYNTHETIC)	ACTIVE INGREDIENT	5TJD82A1ET	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	1
METHYL SALICYLATE	ACTIVE INGREDIENT	LAV5U5022Y	1
CAMPHOR (SYNTHETIC)	ACTIVE MOIETY	5TJD82A1ET	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	1
METHYL SALICYLATE	ACTIVE MOIETY	LAV5U5022Y	1
ALMASILATE	INACTIVE INGREDIENT	OZQ8O62H53	1
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	1
DIHYDROXYALUMINUM AMINOACETATE	INACTIVE INGREDIENT	DO250MG0W6	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	1
SODIUM POLYACRYLATE (8000 MW)	INACTIVE INGREDIENT	285CYO341L	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	1
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

SMART PRO MEDICATED ANALGESIC PAIN RELIEVING CATAPLASM
Camphor, Menthol, Methyl Salicylate
CAMPHOR (SYNTHETIC)
MENTHOL
METHYL SALICYLATE
BUTYLATED HYDROXYTOLUENE
DIHYDROXYALUMINUM AMINOACETATE
EDETATE DISODIUM
GELATIN
GLYCERIN
KAOLIN
ALMASILATE
METHYLPARABEN
POLYSORBATE 80
POLYVINYL ALCOHOL
WATER
SODIUM POLYACRYLATE (8000 MW)
SORBITAN SESQUIOLEATE
TARTARIC ACID
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76092-101	76092-101-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAMPHOR (SYNTHETIC)	5TJD82A1ET	ACTIB
MENTHOL	L7T10EIP3A	ACTIB
METHYL SALICYLATE	LAV5U5022Y	ACTIB
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
DIHYDROXYALUMINUM AMINOACETATE	DO250MG0W6	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
KAOLIN	24H4NWX5CO	IACT
ALMASILATE	OZQ8O62H53	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
POLYVINYL ALCOHOL	532B59J990	IACT
WATER	059QF0KO0R	IACT
SODIUM POLYACRYLATE (8000 MW)	285CYO341L	IACT
SORBITAN SESQUIOLEATE	0W8RRI5W5A	IACT
TARTARIC ACID	W4888I119H	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 483 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, FILM COATED / ORAL	20 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	DROPS / ORAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	INJECTION / INTRAMUSCULAR		11 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
DIHYDROXYALUMINUM AMINOACETATE	DIHYDROXYALUMINUM AMINOACETATE	DO250MG0W6	TABLET / ORAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SHAMPOO / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	INJECTION / INTRACAVITARY	0.05 ml		Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET, COATED / ORAL	52.44 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	SUPPOSITORY / RECTAL		43 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAVENOUS		1170 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / OPHTHALMIC		8 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM, AUGMENTED / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	8 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	LOTION / TOPICAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	TABLET, COATED / ORAL	10 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	TABLET, ORALLY DISINTEGRATING / ORAL		45 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		11 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / EPIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	SYSTEM / TOPICAL		349 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	CAPSULE, EXTENDED RELEASE / ORAL		1325 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / ORAL		72 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GUM, CHEWING / BUCCAL		182 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GELATIN	GELATIN	2G86QN327L	TABLET, ORALLY DISINTEGRATING / SUBLINGUAL		13 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
KAOLIN	KAOLIN	24H4NWX5CO	SYRUP / ORAL	10 mg/1ml		Exact identifier — unii candidate 13 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER / RESPIRATORY (INHALATION)	2 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	TABLET, FILM COATED / ORAL		30 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ELIXIR / ORAL	2.5 mg/15ml		Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, COATED / ORAL	0.7 mg		Exact identifier — unii candidate 17 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fd8d9ad8-bfeb-49b9-90e7-37cf335a8cb5			ad334d10-9053-4c40-96a5-db7236564542	2011-06-20	Warnings	Exact identifier spl id: fd8d9ad8-bfeb-49b9-90e7-37cf335a8cb5 spl set id: ad334d10-9053-4c40-96a5-db7236564542

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.