Active Ingredient
Minoxidil 5%
Olivita Minoxidil Solution
FDA Label NDC 83818-031
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Xinxin Yunhai Technology Co., Ltd. for the product Olivita Minoxidil (NDC 83818-031). 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, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Hair regrowth treatment
Use
to regrow hair on the scalp
Warnings
For external use only.
Do Not Use
Pregnant, Feeding, Heart sensibility, Super-sensitive skin, an open wound, since that can cause irritations; Scalp is red, inflamed, infected, irritated, or painful; You use other medicines on the scalp.
When Using
• Do not apply to other parts of the body.
• Avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water.
• It takes time to regrow hair. Use 2 times a day for at least 4 months before seeing results.
• The amount of hair regrowth varies for each person.
Stop Use
• Chest pain, rapid heartbeat, faintness, or dizziness occurs. Sudden, unexplained weight gain occurs.
• Your hands or feet swell.
• Scalp irritation or redness occurs.
• Unwanted facial hair growth develops.
• No hair regrowth is seen in 4 months.
Ask Doctor
• Chest pain, rapid heartbeat, faintness, or dizziness occurs. Sudden, unexplained weight gain occurs.
• Your hands or feet swell.
• Scalp irritation or redness occurs.
• Unwanted facial hair growth develops.
• No hair regrowth is seen in 4 months.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Apply 1ml directly to the treated scalp area.
• Massage into the scalp and wash hands thoroughly.
• Visible results may take 2 months with twice-daily application.
• For some, at least 4 months of use may be needed. Effectiveness varies.
Other Information
Before use, read all information on the carton.
Store at 20 to 25°C (68 to 77°F).
Inactive Ingredients
alcohol, propylene glycol, purified water
Questions
Email at [email protected]
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