83804-008 Hair Growth Foam

83804-008 Hair Growth Foam
SPL v1
SPL
SPL Set ID 3ceecb17-b013-f957-e063-6394a90ae2ed
Route
TOPICAL
Published
Effective Date 2025-08-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Water Glycerin 1-butene Niacinamide Reynoutria Multiflora Whole Caffeine Sodium Cocoyl Glycinate Diethyl Ethanolamine Platycladus Orientalis Whole Bisphenol A Biotin Sodium Hyaluronate Hydroxyacetophenone Zanthoxylum Bungeanum Fruit Ligustrum Lucidum Fruit Glycol Ligusticum Wallichii Root 3-o-ethyl Ascorbic Acid Panthenol Rosa Canina Fruit Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-22

Description

MINOXIDIL 5%


Medication Information

Warnings and Precautions



For external use only.

Flammable: Keep away from fire or flame

Indications and Usage

to regrow hair on the top of the scalp

Dosage and Administration



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 im-prove results

continued use is necessary to incre-ase and keep your hair regrowth, or hair loss will begin again

Description

MINOXIDIL 5%

Section 50565-1

If swallowed,get medical help or con-tact a Poison Control Center right away.(1-800-222-1222)

Section 50566-9



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

Section 50567-7



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 chan-ges in hair color and/or texture

it takes time to regrow hair. Results may occur at 2 months with twice a day us-age. For some men, you may need to use this product for at least 4 months before you see results

Section 50570-1



you have no family history of hair loss

your hair loss is sudden and/or patchy

you do not know the reason for yourhair loss

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

your scalp is red, inflamed, infectedirritated or painful

you use other medicines on the scalp

Section 51727-6

water

minoxidil

glycerin

butylene

glycol

niacinamide

capilia longa biota orientalis leaf extract

polygonum multiflorumextract

ligustrum lucidum fruit

extractligusticum chuanxiong root

extract zanthoxylum bungeanum

fruit extract 3-o-ethylascorbic acid

rosa canina fruit oil

sodium cocoyl glycinate

biotin

panthenol

caffeine

sodium hyaluronate

diso-dium edta

hydroxyacetophenone

1.2-nexanedi0l

Section 51945-4

Section 55105-1

Hair Regrowth Treatment

Section 55106-9

MINOXIDIL 5%


Structured Label Content

Indications and Usage (34067-9)

to regrow hair on the top of the scalp

Dosage and Administration (34068-7)



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 im-prove results

continued use is necessary to incre-ase and keep your hair regrowth, or hair loss will begin again

Warnings and Precautions (34071-1)



For external use only.

Flammable: Keep away from fire or flame

Section 50565-1 (50565-1)

If swallowed,get medical help or con-tact a Poison Control Center right away.(1-800-222-1222)

Section 50566-9 (50566-9)



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

Section 50567-7 (50567-7)



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 chan-ges in hair color and/or texture

it takes time to regrow hair. Results may occur at 2 months with twice a day us-age. For some men, you may need to use this product for at least 4 months before you see results

Section 50570-1 (50570-1)



you have no family history of hair loss

your hair loss is sudden and/or patchy

you do not know the reason for yourhair loss

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

your scalp is red, inflamed, infectedirritated or painful

you use other medicines on the scalp

Section 51727-6 (51727-6)

water

minoxidil

glycerin

butylene

glycol

niacinamide

capilia longa biota orientalis leaf extract

polygonum multiflorumextract

ligustrum lucidum fruit

extractligusticum chuanxiong root

extract zanthoxylum bungeanum

fruit extract 3-o-ethylascorbic acid

rosa canina fruit oil

sodium cocoyl glycinate

biotin

panthenol

caffeine

sodium hyaluronate

diso-dium edta

hydroxyacetophenone

1.2-nexanedi0l

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair Regrowth Treatment

Section 55106-9 (55106-9)

MINOXIDIL 5%


Advanced Ingredient Data


Raw Label Data

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