SATOGESIC- 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:

Fuji Seal, Inc.

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

SATOGESIC- DL-CAMPHOR, L-MENTHOL, METHYL SALICYLATE PATCH
FUJI SEAL, INC.
_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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DRUG FACTS
_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 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 were applied. Read and follow all directions
and warnings on
this label.
KEEP OUT OF REACH OF CHILDREN TO AVOID ACCIDENTAL POISONING. 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.
_OTH