Satogesic DL CAMPHOR L MENTHOL METHYL SALICYLATE SATO PHARMACEUTICAL CO., LTD. FDA Approved Uses temporary relieves minor aches and pains of muscles and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains
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Substance Camphor Synthetic
Route
TOPICAL
Applications
M017

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients dl-Camphor 0.5% l-Menthol 0.4% Methyl salicylate 0.8%
Inactive Ingredients
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.
Strengths
0.5 % 0.4 % 0.8 %
Treats Conditions
Uses Temporary Relieves Minor Aches And Pains Of Muscles And Joints Associated With Simple Backache Arthritis Strains Bruises Sprains

Identifiers & Packaging

Container Type BOX
UNII
5TJD82A1ET BZ1R15MTK7 LAV5U5022Y
Packaging

Carton

Package Descriptions
  • Carton

Overview

Uses temporary relieves minor aches and pains of muscles and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Indications & Usage

Uses temporary relieves minor aches and pains of muscles and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Dosage & 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.

Warnings & Precautions
Warnings For external use only Do not use ■ on irritated, broken, or damaged skin ■ on wounds ■ otherwise than as directed 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 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) 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. Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.
Purpose

Purpose dl-Camphor External analgesic l-Menthol External analgesic Methyl salicylate External analgesic

Do Not Use

Do not use ■ on irritated, broken, or damaged skin ■ on wounds ■ otherwise than as directed

When Using

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

Stop Use & Ask a Doctor

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)

Keep Out of Reach of Children

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

Storage & Handling

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


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