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Satogesic

Sato Pharmaceutical Co., Ltd.

DRUG FACTS




FULL PRESCRIBING INFORMATION

Active ingredient

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

Purpose

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

Uses

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

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.

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.

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

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.

Satogesic

Satogesic

Satogesic

dl-camphor, l-menthol, methyl salicylate PATCH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49873-060
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) 5 mg
LEVOMENTHOL 4 mg
methyl salicylate METHYL SALICYLATE 8 mg

Inactive Ingredients

Ingredient Name Strength
CARBOXYMETHYLCELLULOSE SODIUM
POLYVINYL ALCOHOL
sorbitol
GLYCERIN
titanium dioxide
EDETATE DISODIUM
Malic Acid
water
POLYOXYL 60 HYDROGENATED CASTOR OIL
algeldrate
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 POUCH
2 5 in 1 POUCH
3 NDC:49873-060-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 1990-12-03


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Be sure to consult your doctor before taking any medication!
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