5% Minoxidil Hair Growth Topical Solution
85304-018 5% Minoxidil Hair Growth Topical Solution
3e569e69-55b9-1d01-e063-6294a90a88ed
HUMAN OTC DRUG LABEL
Sep 9, 2025
Guangzhou Borderless Technology Co., Ltd.
DUNS: 452282332
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Minoxidil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Use to regrow hair and beard.
OTC - ACTIVE INGREDIENT SECTION
Minoxidil 5%
Biotin 0.5%
OTC - PURPOSE SECTION
Hair Regrowth Treatment
WARNINGS SECTION
Keep out of reach of children.
For external use only
OTC - DO NOT USE SECTION
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.
OTC - WHEN USING SECTION
Avold contact with the eves. in case of accidental contact, rinse eves 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 3 months with twice a day
usage. For some men, you may need to use this product for at least 6 months
before you see results. The amount of hair regrowth is diferent for each
person.
Avoid contact with eyes. in case of accidental contact, rinse eyes with a
large amount of cool tap water.
OTC - STOP USE SECTION
Chest pain, rapid heartbeat, faintness, or dizziness occurs.
Sudden, unexplained weight gain occurs.
lf unwanted facial hair growth occurs
lf you do not see hair regrowth in 6 months.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. f swallowed, get medical help or contact a
Poison Control Center
(1-800-222-1222)right away.
DOSAGE & ADMINISTRATION SECTION
1. After opening the cap, apply 1 ml by pressing and dotting onto the scalp
area to be treated.
2. Gently massage the scalp or sparse hair area until fully absorbed.
3. Use twice daily.
4. Continuous use is necessary to increase and maintain har regrowth.
Stopping use may lead to hair loss
INACTIVE INGREDIENT SECTION
Butylene Glycol
Glycerin
Alcohol
Castor oil
Dexpanthenol
Water