Otc - Active Ingredient
Minoxidil 5%
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Xingdaren 5% Minoxidil With Biotin Topical Vimoza Liquid
FDA Label NDC 87710-010
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 Xingdaren 5% Minoxidil With Biotin Topical Vimoza (NDC 87710-010). 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, warnings, otc - do not use, otc - when using, otc - stop use, 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 Treatment
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Warnings
• For external use only.
• Keep away from fire and flame.
• Avoid contact with eyes.
• May be harmful if used when pregnant or breast-feeding.
ASK DOCTOR: If you have chest pain, rapid heart beat, faintness, or dizziness occurs.
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Otc - Do Not Use
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• You have no family history of hair loss. 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 it on babies and children.
• Scalp is red, inflamed, infected, irritated or painful.
• You use other medicines on the scalp.
Otc - When Using
Do not apply on other parts of the body. Avoid contact with eyes.
In case of accidental contact, rinse eyes with a large amount of cool tap water.
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It takes time to regrow hair. You may need to use this product 2 times a day for at least 4 months before you see results. The amount of hair regrowth is different for each person. The product will not work for everyone.
Otc - Stop Use
• If scalp irritation or redness occurs.
• If you get unwanted facial hair growth.
• If you do not see hair regrowth in 4 months.
• If sudden, unexplained weight gain occurs.
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Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
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Avoid contact between children and minoxidil application sites.
Avoid contact between pets and minoxidil application sites.
Dosage & Administration
• Prime the sprayer by holding the bottle upright and pumping 5 times before first use.
• Apply 1 mL (5 sprays) 2 times a day directly onto the scalp in the hair loss area.
• Using more or more often will not improve results.
• Continuous use is helpful in promoting and maintaining hair regrowth. If you plan to stop using it later, do not stop abruptly. Instead, gradually reduce the frequency of use; otherwise, hair loss may resume.
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Storage And Handling
Store at controlled room temperature 20 to 25°C (68 to 77°F).
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Inactive Ingredient
Water, Propylene glycol, Glycerin, Zingiber officinale (Ginger) root extract, PEG-40 hydrogenated castor oil, Panax ginseng extract, Biotin, Xanthan gum, Ricinus communis (Castor) oil, Rosmarinus officinalis (Rosemary) leaf oil.
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Indications & Usage
To regrow hair on the top of the scalp
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Package Label.Principal Display Panel
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* Please review the disclaimer below.
