FDA Label for Satohap
View Indications, Usage & Precautions
Satohap Product Label
The following document was submitted to the FDA by the labeler of this product Sato Pharmaceutical Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients
dl-Camphor 5%
l-Menthol 4%
Methyl salicylate 10%
Otc - Purpose
Purpose
dl-Camphor External analgesic
l-Menthol External analgesic
Methyl salicylate External analgesic
Indications & Usage
Uses
temporarily relieves minor aches and pains of muscles and joints due to
■ backache ■ arthritis ■ strains ■ bruises ■ sprains
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use
■ on wounds
■ on damaged or irritated skin
Otc - When Using
When using this product
■ avoid contact with the eyes and mucous membranes
■ do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
■ excessive irritation develops
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ when using for pain of arthritis if:
■ pain persist for more than 10 days
■ redness is present
■ in conditions affecting children under 12 years of age
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
■ adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily.
■ children under 2 years of age: do not use, ask a doctor.
Inactive Ingredient
Inactive ingredients
edetate disodium, alcohol, propylene glycol, water
Package Label.Principal Display Panel
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