Otc - Active Ingredient
Minoxidil 5% w/v
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Vimoza 5% Minoxidil With Biotin Topical Liquid
FDA Label NDC 87710-009
12 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 Vimoza 5% Minoxidil With Biotin Topical (NDC 87710-009). 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, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Hair regrowth treatment
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Indications & Usage
Uses to regrow hair on the top of the scalp
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Warnings
• For external use only.
• Keep away from fire or flame.
• Ask a doctor before use if you have heart disease.
• May be harmful if used when pregnant or breast-feeding.
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Otc - Do Not Use
• Your amount of hair loss is different from that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or a receding hairline.
• You have no family history of hair loss.
• Your hair loss is sudden and/or patchy.
• You do not know the reason for your hair loss.
• You are under 18 years of age. Do not use on babies and children.
• Your scalp is red, inflamed, infected, irritated, or painful.
• You use other medicines on the scalp.
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Otc - When Using
• Do not apply on other parts of the body.
• Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
• Some people have experienced changes in hair color and/or texture.
• It takes time to regrow hair. Results may occur at 2 months with twice-a-day use. For some men, you may need to use this product for at least 4 months before you see results.
• The amount of hair regrowth is different for each person. This product will not work for all men.
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Otc - Stop Use
• Apply one mL (5 sprays) twice a day directly onto the scalp in the hair loss area.
• Using more or more often will not improve results.
• Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.
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Storage And Handling
Avoid freezing and excessive heat above 40C (104F) ）
Store at 20° to 25°C (68° to 77°F). Keep tightly closed.
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Dosage & Administration
• Apply one mL (5 sprays) twice a day directly onto the scalp in the hair loss area.
• Using more or more often will not improve results.
• Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.
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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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Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
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Package Label.Principal Display Panel
label
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