Happy Head Womens Hair Regrowth Treatment Solution
FDA Label NDC 87117-880

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Happy Head, Inc for the product Happy Head Womens Hair Regrowth Treatment (NDC 87117-880). 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 active ingredient, purpose, use, warnings, do not use if:, ask a doctor before use if, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment for women

Use

to regrow hair on the scalp

Warnings

For external use only.

Flammable: Keep away from fire or flame

Do Not Use If:

• your amount 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 childbirth • 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

Ask A Doctor Before Use If

you have heart disease

When Using This Product

• 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. 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. This product will not work for all women.

Stop Use And Ask A Doctor If

• 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

May Be Harmful If Used When Pregnant Or Breast-Feeding.

Keep Out Of Reach Of Children.

If swallowed, get medical help, or contact a Poison Control Center right away.

Directions

• apply one mL with dropper 2 times 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 

Other Information

• see hair loss pictures on side of this carton • before use, read all information on carton and enclosed leaflet • keep the carton. 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 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution 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 controlled room temperature 20° to 25°C (68° to 77°F).

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions Or Comments?

1-844-962-4247 Visit Website at www.happyhead.com/help

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