Otc - Active Ingredient
Active ingredients
dl-Camphor 5%
l-Menthol 4%
Methyl salicylate 10%
Satohap Lotion
FDA Label NDC 49873-065
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Satohap (NDC 49873-065). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Satohaplotioncart.jpg
SatohaplotionPDP.jpg
SatohaplotionPDP.jpg
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