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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sato Pharmaceutical Co., Ltd.

INN (International Name):

METHYL SALICYLATE

Composition:

METHYL SALICYLATE 10 g in 100 mL

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 due to ■ backache   ■ arthritis   ■ strains   ■ bruises   ■sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

SATOHAP- METHYL SALICYLATE, DL-CAMPHOR, L-MENTHOL SPRAY
SATO PHARMACEUTICAL CO., LTD.
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SATOHAP SPRAY
ACTIVE INGREDIENTS
dl-Camphor 5%
l-Menthol 4%
Methyl salicylate 10%
PURPOSE
dl-Camphor External analgesic
l-Menthol External analgesic
Methyl salicylate External analgesic
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.
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 INGREDIENTS
fragrance, phenylethyl alcohol, alcohol, propylene glycol, LPG
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
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
ALCOHOL (UNII: 3K9958V90M)
LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MA