FDA Label for Minoxidil Solution
View Indications, Usage & Precautions
Minoxidil Solution Product Label
The following document was submitted to the FDA by the labeler of this product Nutrastim Hair Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
To regrow hair on the scalp.
Warnings
- For external use only.
- For use by women only.
- Flammable. Keep away from fire or flame.
Otc - Do Not Use
- Your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you.
- You have no family history of hair loss.
- Your hair loss is sudden and/or patchy.
- Your hair loss is associated with child birth.
- 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.
Otc - Ask Doctor
Ask a doctor before use if you have heart disease
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 usage. For some women, you may need to use this product for at least 4 months before you see results.
- The amount of hair regrowth is different with each person. This product will not work for all women.
Otc - 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 occurs.
- You do not see hair regrowth in 4 months.
Otc - Pregnancy Or Breast Feeding
May be harmful if used when pregnant or breast-feeding.
Otc - Keep Out Of Reach Of Children
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 1 ml, 2 times daily directly with the dropper 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.
Other Information
- Before use see hair loss pictures on side of this box.
- Keep the box, it contains important information.
- In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution was 2% was reported: 19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth: 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth).
- Store at 20° to 25° C (68° to 77° F).
Keep tightly closed.
Inactive Ingredient
Alcohol, propylene glycol, purified water
Otc - Questions
Call us at 1-844-892-8578
Visit nutrastimhair.com
for more information about hair thinning, visit
nutrastimhair.com/women-education/
Otc - Active Ingredient
Minoxidil 2% w/v
Package Label.Principal Display Panel
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