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

Satohap by

Drug Labeling and Warnings

Satohap by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INDICATIONS & USAGE

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

WARNINGS

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.

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.

INACTIVE INGREDIENT

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.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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
BUTYL ACRYLATE/METHACRYLIC ACID COPOLYMER (2% METHACRYLIC ACID) (UNII: Q984S31CYH)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
POLYVINYL ALCOHOL (UNII: 532B59J990)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALGELDRATE (UNII: 03J11K103C)
MALIC ACID (UNII: 817L1N4CKP)
WATER (UNII: 059QF0KO0R)
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-018-05	1 in 1 CARTON	11/08/1989
1		5 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 49873-018-02	1 in 1 CARTON	11/08/1989
2		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/08/1989

Labeler - Sato Pharmaceutical Co., Ltd. (690575642)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	label(49873-018) , pack(49873-018) , manufacture(49873-018)