Satogessic Medicated Adhesive Pads

Satogessic Medicated Adhesive Pads
SPL v5
SPL
SPL Set ID cb000134-92a4-4304-8ef0-0347190e1414
Route
TOPICAL
Published
Effective Date 2013-09-19
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
Carboxymethylcellulose Sodium Polyvinyl Alcohol Sorbitol Glycerin Titanium Dioxide Edetate Disodium Malic Acid Water Polyoxyl 60 Hydrogenated Castor Oil Algeldrate Butyl Acrylate/methacrylic Acid Copolymer (2% Methacrylic Acid) Carbomer 940 Acrylic Acid/sodium Acrylate Copolymer (1:1; 600 Mpa.s At 0.2%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1990-12-03

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 44425-7

Other Information

■ keep pouch tightly closed until ready to use   ■ store at room temperature (20° to 25°C or 68° to 77°F)

Section 50565-1

Keep out of reach of children to avoid accidental poisoning. 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 within a few days

■ excessive irritation of the skin develops ■ nausea, vomiting,

abdominal discomfort, diarrhea, or skin rash occurs

■ when using for pain of arthritis:

■ pain persists for more than 10 days ■ redness is present ■ in conditions

affecting children under 12 years of age

■ you experience pain, swelling, or blistering of the skin (this product should not cause

pain or skin damage)

Section 50567-7

When using this product



■ avoid contact with the eyes or mucous membranes ■ do not bandage the area

tightly and do not apply local heat (heating pads, lamps, hot water in bags or bottles)

because doing so can increase the risk of serious burns

Section 50570-1

Do not use

■ on irritated, broken, or damaged skin    ■ on wounds    ■ otherwise than as directed

Section 51727-6

Inactive ingredients

carbomer 940, carboxymethylcellulose sodium, dried aluminum hydroxide gel, 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%

Section 60561-8

Warning - Rare cases of serious burns have been reported to occur on the skin where

OTC external analgesics were applied. Read and follow all directions and warnings on

this label.


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 44425-7 (44425-7)

Other Information

■ keep pouch tightly closed until ready to use   ■ store at room temperature (20° to 25°C or 68° to 77°F)

Section 50565-1 (50565-1)

Keep out of reach of children to avoid accidental poisoning. 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 within a few days

■ excessive irritation of the skin develops ■ nausea, vomiting,

abdominal discomfort, diarrhea, or skin rash occurs

■ when using for pain of arthritis:

■ pain persists for more than 10 days ■ redness is present ■ in conditions

affecting children under 12 years of age

■ you experience pain, swelling, or blistering of the skin (this product should not cause

pain or skin damage)

Section 50567-7 (50567-7)

When using this product



■ avoid contact with the eyes or mucous membranes ■ do not bandage the area

tightly and do not apply local heat (heating pads, lamps, hot water in bags or bottles)

because doing so can increase the risk of serious burns

Section 50570-1 (50570-1)

Do not use

■ on irritated, broken, or damaged skin    ■ on wounds    ■ otherwise than as directed

Section 51727-6 (51727-6)

Inactive ingredients

carbomer 940, carboxymethylcellulose sodium, dried aluminum hydroxide gel, 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%

Section 60561-8 (60561-8)

Warning - Rare cases of serious burns have been reported to occur on the skin where

OTC external analgesics were applied. Read and follow all directions and warnings on

this label.


Advanced Ingredient Data


Raw Label Data

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