Satogesic by Sato Pharmaceutical Co., Ltd. Satogesic Spray; De-list

Drug Details [pdf]

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; De-list

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

Inactive ingredients

alcohol, fragrance, liquefied petroleum gas, phenylethyl alcohol, propylene glycol

Carton

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49873-067
Route of Administration	TOPICAL

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 49873-067-01	100 mL in 1 CAN; Type 0: Not a Combination Product	11/25/1991	01/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/25/1991	01/01/2016

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

Name	Address	ID/FEI	Business Operations
Establishment
Sato Pharmaceutical Co., Ltd.		715699133	manufacture(49873-067)

Revised: 4/2020

Document Id: a387b7b1-b397-1a9a-e053-2a95a90a27bf

Set id: 0c121484-61de-4295-a85b-10791320fc1b

Version: 3

Effective Time: 20200417

Sato Pharmaceutical Co., Ltd.