Satohap Plaster

Satohap Plaster
SPL v4
SPL
SPL Set ID df0e2b83-8f61-4ed8-bcc4-55e4ea782090
Route
TOPICAL
Published
Effective Date 2012-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (5 mg) Levomenthol (4 mg) Salicylic Acid (8 mg)
Inactive Ingredients
Polyvinyl Alcohol Sorbitol Glycerin Titanium Dioxide Edetate Disodium Algeldrate Malic Acid Water Polyoxyl 60 Hydrogenated Castor Oil Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%) Carboxymethylcellulose Sodium Butyl Acrylate/methacrylic Acid Copolymer (2% Methacrylic Acid) Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1989-11-08

Description

Active ingredients dl-Camphor 0.5% l-Menthol 0.4% Methyl Salicylate 0.8%


Medication Information

Warnings and Precautions

Warnings

For external use only



Indications and Usage

Uses  temporary relieves minor aches and pains of muscles and joints associated with

■ simple backache    ■ arthritis    ■ strains    ■ bruises    ■ sprains

Dosage and Administration

Directions

■ Strip off the polyethylene film and place adhesive pad over affected area.

■ Change pad 1 or 2 times a day

■ Not for children under 4 years.

Description

Active ingredients dl-Camphor 0.5% l-Menthol 0.4% Methyl Salicylate 0.8%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.





Section 50566-9

Stop use and ask a doctor if



■ condition worsens



■ symptoms persist for more than 7 days



■ symptoms clear up and occur again withn a few days





Section 50567-7

When using this product



■ avoid contact with the eyes



■ do not bandage tightly

Section 50570-1

Do not use



■ on wounds or on damaged skin

Section 51727-6

Inactive ingredients

aluminum hydroxide gel, carbomer, carmellose sodium, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, partially hydrolyzed polyvinyl alcohol, partially neutralized polyacrylate, PEG 60 hydrogenated castor oil, sorbitol, titanium dioxide, water.

Section 51945-4

Section 55105-1

Purpose

dl-Camphor    External analgesic

l-Menthol        External analgesic

Methyl Salicylate      External analgesic

Section 55106-9

Active ingredients

dl-Camphor 0.5%

l-Menthol 0.4%

Methyl Salicylate 0.8%


Structured Label Content

Indications and Usage (34067-9)

Uses  temporary relieves minor aches and pains of muscles and joints associated with

■ simple backache    ■ arthritis    ■ strains    ■ bruises    ■ sprains

Dosage and Administration (34068-7)

Directions

■ Strip off the polyethylene film and place adhesive pad over affected area.

■ Change pad 1 or 2 times a day

■ Not for children under 4 years.

Warnings and Precautions (34071-1)

Warnings

For external use only



Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.





Section 50566-9 (50566-9)

Stop use and ask a doctor if



■ condition worsens



■ symptoms persist for more than 7 days



■ symptoms clear up and occur again withn a few days





Section 50567-7 (50567-7)

When using this product



■ avoid contact with the eyes



■ do not bandage tightly

Section 50570-1 (50570-1)

Do not use



■ on wounds or on damaged skin

Section 51727-6 (51727-6)

Inactive ingredients

aluminum hydroxide gel, carbomer, carmellose sodium, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, partially hydrolyzed polyvinyl alcohol, partially neutralized polyacrylate, PEG 60 hydrogenated castor oil, sorbitol, titanium dioxide, water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

dl-Camphor    External analgesic

l-Menthol        External analgesic

Methyl Salicylate      External analgesic

Section 55106-9 (55106-9)

Active ingredients

dl-Camphor 0.5%

l-Menthol 0.4%

Methyl Salicylate 0.8%


Advanced Ingredient Data


Raw Label Data

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