Inlifay Minoxidil Topical Liquid
FDA Label NDC 87710-008

14 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 Inlifay Minoxidil Topical (NDC 87710-008). 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, use, warning, do not use if, when using this product, stop use and ask doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Otc - Purpose

→ Use

→ Warning

→ Do Not Use If

→ When Using This Product

→ Stop Use And Ask Doctor If

→ Keep Out Of Reach Of Children

→ Storage And Handling

→ Inactive Ingredients

→ Direction

→ Ask A Doctor Before Use If

→ May Be Harmful If

→ Label

Otc - Active Ingredient

Minoxidil 5% w/v

Otc - Purpose

Hair regrowth treatment

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warning

For external use only

Keep away from fire or flame

Do Not Use If

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 areceding hairline.

You have no family history of hair loss.

Your hair loss is sudden and/orpatchy.

You do not know the reason for your hair loss.

You are under 18 years of age. Do notuse on babies and children.

Your scalp is red, inflamed, infected, irritated, or painful.

You use other medicines on the scalp.

When Using This Product

Do not apply on other parts of the body.

Avoid contact with the eyes. In case of accidentalcontact, rinse eyes with large amounts of cool tap water.

Some people have experiencedchanges in hair color and/or texture.

It takes time to regrow hair. Results may occur at 2 monthswith twice-a-day use. For some men, you may need to use this product for at least 4 monthsbefore you see results.

The amount of hair regrowth is different for each person. This product will not work for all men.

Stop Use And Ask Doctor If

Chest pain, rapid heartbeat, faintness, or dizziness occurs.

Sudden, unexplained weightgain occurs.

Your hands or feet swell.

Scalp irritation or redness occurs.

Unwanted facialhair growth occurs.

You do not see hair regrowth in 4 months

Keep Out Of Reach Of Children

if swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Storage And Handling

See hair loss pictures on side of this carton.

Before use,reacall information on carton andenclosed leaflet.

Keep the carton. It contains important information.

Hair regrowth hasnot been shown to last longerthan 48 weeks in large clinicaltrials with continuous treatmentwith 5% minoxidil topical solutiofor men.

Store at controlledroom temperature 20° to 25°C(68°to 77°F).