Active Ingredient(S)
Minoxidil Sulfate. 3%
BIOTIN 1%
Hair Regrowth
FDA Label NDC 84148-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ariel Biotech Co., Ltd. for the product Hair Regrowth (NDC 84148-007). 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 active ingredient(s), purpose, use, warnings, 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
Purpose
Hair regrowth treatment
Anti-hair loss
Use
Use: To regrow hair of scalp and beard
Warnings
Warnings: For external use only. Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Keep out of reach of children.If you are pregnant, nursing, or have any underlying medical condition,
consult your healthcare provider before using the product.
Do Not Use
Do not use: on broken or irritated scalp.
Otc - When Using
When Using Section: When using this product, avoid contact with eyes. If contact occurs, rinse
thoroughly with water. Discontinue use if any irritation or adverse reaction occurs.
Otc - Stop Use
●Chest pain, rapid heartbeat, faintness or dizziness occurs.
●Scalp iritation or redness occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Directions
Directions: Shake the bottle well, hold it about 6 inches away from your scalp, and spray evenly over
the desired areas. Massage gently to help absorption.
Other Information
No Data
Inactive Ingredients
Inactive ingredients: Aroma, Caffeine, Ethylhexylglycerin, Hyaluronic Acid, Peg-40 Hydrogenated Castor Oil,
Phenoxyethanol, Propylene Glycol, Water.
Package Label - Principal Display Panel
Label (Label)
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