MINOXIDIL HAIR GROWTH FOAM aerosol, foam

MINOXIDIL HAIR GROWTH FOAM by

Drug Labeling and Warnings

MINOXIDIL HAIR GROWTH FOAM by is a Otc medication manufactured, distributed, or labeled by Guangzhou Yibai Technology Sarl. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Minoxidil 5% w/w (without propellant)

Diaminopyrimidine oxide 3%

PURPOSE

Hair regrowth treatment

Treat hair loss caused by premature loss of hair roots

INDICATIONS & USAGE

Treatment of hair loss and alopecia areata

WARNINGS

For external use only.

Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

DO NOT USE

You are allergic to any of the ingredients

You have no family history of hair loss.

Your hair loss is sudden and/or patchy.

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

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 one, you may need to use this product for at least 4 months before you see results.The amount of hair regrowth is different for each person. This product will notwork for all.

STOP USE

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.

KEEP OUT OF REACH OF CHILDREN

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(1-800-222-1222)

DOSAGE & ADMINISTRATION

Apply evenly to hair loss areas twice a day and massage scalp for 1-2 minutes until absorbed,then wash hands well.See enclosed leaflet for complete directions how to use.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

STORAGE AND HANDLING

Store at controlled room temperature 20° to 25℃ (68° to 77°F) Contents under pressure.

Do not puncture or incinerate container.

Do not expose to heat or store at temperatures above 120°F (49℃)

INACTIVE INGREDIENT

1.2-propylene glycol 37%, ethanol 25%, water 30%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINOXIDIL HAIR GROWTH FOAM 
minoxidil hair growth foam aerosol, foam

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84315-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIAMINOPYRIMIDINE OXIDE (UNII: 1756681479) (DIAMINOPYRIMIDINE OXIDE - UNII:1756681479)	DIAMINOPYRIMIDINE OXIDE	3 g  in 100 g
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84315-001-01	60 g in 1 CANISTER; Type 0: Not a Combination Product	05/09/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075357	05/09/2024

Labeler - Guangzhou Yibai Technology Sarl (281523247)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yibai Technology Sarl		281523247	manufacture(84315-001)