Otc - Active Ingredient
Panthenol
Roota Re F Tonic
FDA Label NDC 54576-3001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raphabio Inc for the product Roota Re F Tonic (NDC 54576-3001). 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, inactive ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Aqua (Water), sd alcohol 40, butylene glycol, peg-40 hydrogenated castor oil, polysorbate 80, urea, menthol, salicylic acid, glycolic acid, dipotassium glycyrrhizate, camphor, tocopheryl acetate, peppermint oil, allantoin, sodium citrate, zinc sulfate, disodium edta, rosemary leaf oil, niacinamide, panax ginseng root extract, pyridoxine hci, sophora angustifolia root extract, acorus calamus root extract, polygonum multiflorum root extract, morus alba bark extract, licorice root extract, ginkgo biloba leaf extract, copper tripeptide-1
Otc - Purpose
Hair care
Otc - Keep Out Of Reach Of Children
Keep out of reach of the children
Indications & Usage
After shampooing, dry your hair and sclap thoroughlyapply the tonic into scalp and gently massage with fingertips to help absorption
Warnings
Stop use if irritation occurs
Dosage & Administration
For external use only
* Please review the disclaimer below.
