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

Satohap by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
dl-Camphor 5%
l-Menthol 4%
Methyl salicylate 10%

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 due to
■ 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

■ symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Warnings-contents under pressure

■ do not puncture or incinerate container.

■ do not expose to heat or store at temperatures above 120 degrees F.

DOSAGE & ADMINISTRATION

Directions
■ adults and children 2 years of age and over: Hold can upright and spray until wet. Apply to affected area not more than 3 to 4 times daily.
■ children under 2 years of age: Do not use and ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients
fragrance, phenylethyl alcohol, alcohol, propylene glycol, LPG

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	10 g  in 100 mL
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	4 g  in 100 mL
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ALCOHOL (UNII: 3K9958V90M)
LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49873-068-02	70 mL in 1 CANISTER; Type 0: Not a Combination Product	11/03/2006

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/03/2006

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

Establishment
Name	Address	ID/FEI	Business Operations
Daizo Corporation		695312298	pack(49873-068) , label(49873-068)

Establishment
Name	Address	ID/FEI	Business Operations
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-068)