Otc - Active Ingredient
Active ingredients
dl-Camphor 5%
l-Menthol 4%
Methyl salicylate 10%
Satohap Spray
FDA Label NDC 49873-068
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 49873-068). 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 temporary relieves minor aches and pains of muscles and joints due to
■ backache ■ arthritis ■ strains ■ bruises ■sprains
Warnings
For external use only
Otc - Do Not Use
Do not use on wounds or on damaged skin
Otc - When Using
When using this product
■ avoid contact with the eyes
■ do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
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.
Safe Handling Warning
Warnings-contents under pressure
■ do not puncture or incinerate container.
■ do not expose to heat or store at temperatures above 120 degrees F.
Dosage & Administration
Directions
■ adults and children 2 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 2 years of age: Do not use and ask a doctor.
Inactive Ingredient
Inactive ingredients
fragrance, phenylethyl alcohol, alcohol, propylene glycol, LPG
Package Label.Principal Display Panel
Carton (Satohapspraycart)
* Please review the disclaimer below.
