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

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 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      temporarily relieves minor aches and pains of muscles and joints due to - simple backache - arthritis - strains - bruises - sprains

Authorization status:

OTC monograph not final

Summary of Product characteristics

SATOGESIC- DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE SPRAY
SATO PHARMACEUTICAL CO., LTD.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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SATOGESIC 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_ temporarily relieves minor aches and pains of muscles and
joints due to
simple backache
arthritis
strains
bruises
sprains
FOR EXTERNAL USE ONLY.
EXTREMELY FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.
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 weere applied. Read and follow all directions and warnings
on this label.
WARNING-CONTENTS UNDER PRESSURE
do not puncture or incinerate container
do not expose to heat or store at temperatures above 120 degrees F.
KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL POISONING.
If swallowed, get medical help or
contact a Poison Control Center right away.
_DIRECTIONS_
adults and children 3 years of age and over: H