SATOHAP- dl-camphor, l-menthol, methyl salicylate patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET), LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

Available from:

Sato Pharmaceutical Co., Ltd.

INN (International Name):

CAMPHOR - UNII:5TJD82A1ET)

Composition:

CAMPHOR (SYNTHETIC) 5 mg

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose dl-Camphor    External analgesic l-Menthol        External analgesic Methyl Salicylate      External analgesic Uses   temporary relieves minor aches and pains of muscles and joints associated with ■ simple backache    ■ arthritis    ■ strains    ■ bruises    ■ sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

SATOHAP- DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE PATCH
SATO PHARMACEUTICAL CO., LTD.
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SATOHAP PLASTER
ACTIVE INGREDIENTS
dl-Camphor 0.5%
l-Menthol 0.4%
Methyl Salicylate 0.8%
PURPOSE
dl-Camphor External analgesic
l-Menthol External analgesic
Methyl Salicylate External analgesic
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 wounds or on damaged skin
WHEN USING THIS PRODUCT
■ avoid contact with the eyes
■ do not bandage tightly
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
KEEP OUT OF REACH OF CHILDREN. 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.
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.
SATOHAP
dl-camphor, l-menthol, methyl salicylate patch
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:49873-018
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) -
UNII:5TJD82A1ET)
CAMPHOR
(SYNTHETIC)
5 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)
LEVOMENTHOL
4 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID -
UNII:O414PZ4LPZ)
METHYL SALICYLATE
8 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
POLYVINYL ALCOHOL (UNII: 532B59J990)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EDETATE DISODIUM (UNII: 7F