Otc - Active Ingredient
Minoxidil 5% w/v
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5% Minoxidil With Biotin Topical Vimoza Liquid
FDA Label NDC 87710-011
11 label sections · Submitted to the FDA by Guangzhou Huanmei Cosmetics Co., Ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Huanmei Cosmetics Co., Ltd. for the product 5% Minoxidil With Biotin Topical Vimoza (NDC 87710-011). 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 - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Hair regrowth
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Indications & Usage
when soap and water are not available.）
Helps regrow thinning hair on the scalp.
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Warnings
• For external use only.
• Flammable: Keep away from fire or flame.
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Otc - Do Not Use
Do not use if:
Scalp is red, inflamed, infected, irritated, or painful.
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Stop use and ask a doctor if:
• Chest pain, rapid heartbeat, faintness, or dizziness occurs.
• Scalp irritation or redness occurs.
• Unwanted facial hair growth occurs.
• Condition worsens or does not improve after regular use.
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Otc - When Using
When using this product:
• Avoid contact with eyes.
• In case of contact, rinse eyes thoroughly with cool tap water.
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Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
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If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Prime Before First Use: Hold the bottle upright and pump the sprayer 3 times to prime it before first use.
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How to Apply: Apply 1 mL (5 sprays) directly to the scalp in the hair loss area twice daily.
• Apply 1 mL with the spray applicator to the thinning area of scalp.
• Use twice daily, morning and night.
• Part hair to expose scalp. Spray directly onto scalp and gently spread with fingers.
• Wash hands thoroughly after use.
Continued Use: Continued use is necessary to promote and maintain hair regrowth. Otherwise, hair loss may begin again.
Visible Results: Visible hair growth may be noticed after 2 months of continuous use.
Storage And Handling
• Store at 20°–25°C (68°–77°F).
• Keep tightly closed.
• Protect from freezing.
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Inactive Ingredient
Aqua, Propylene Glycol, Glycerin, Zingiber Officinale Root Extract, PEG-40 Hydrogenated Castor Oil, Panax Ginseng Extract, Biotin, Xanthan Gum, Ricinus Communis Seed Oil, Rosmarinus Officinalis Leaf Oil.
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Package Label.Principal Display Panel
Label
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