Otc - Active Ingredient
Minoxidil 5%
Minoxidil Topical
FDA Label NDC 83717-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wenchang Panzhijie Trading Co., Ltd. for the product Minoxidil Topical (NDC 83717-004). 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, purpose, use, warnings, do not use, stop use and see a doctor, otc - keep out of reach of children, directions, 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 top of the scalp
Warnings
• For external use only
• Keep away from fire and flame
• Avoid contact with eyes
Do Not Use
• 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 onbabies and children.Scalp is red, inflamed, infected, irritated or painful.
• You use other medicines on the scalp.
Stop Use And See A Doctor
• 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.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
Apply 1ml(5 Sprays) twice a day.Once in the morning and another time in the evening before bed.
Spray directly on top of the scalp in the area to be treated.
Discontinuing use may result in hair loss.
Inactive Ingredients
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.
Package Label.Principal Display Panel
Undefined (Label)
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