MINOXIDIL HAIR GROWTH FOAM- minoxidil hair growth foam aerosol, foam 
Guangzhou Yibai Technology Sarl

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84315-001

Minoxidil 5% w/w (without propellant)

Diaminopyrimidine oxide 3%

Hair regrowth treatment

Treat hair loss caused by premature loss of hair roots

Treatment of hair loss and alopecia areata

For external use only.

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

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

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 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(1-800-222-1222)

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

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℃)

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

84315-001-01

MINOXIDIL HAIR GROWTH FOAM 
minoxidil hair growth foam aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84315-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIAMINOPYRIMIDINE OXIDE (UNII: 1756681479) (DIAMINOPYRIMIDINE OXIDE - UNII:1756681479) DIAMINOPYRIMIDINE OXIDE3 g  in 100 g
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84315-001-0160 g in 1 CANISTER; Type 0: Not a Combination Product05/09/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07535705/09/2024
Labeler - Guangzhou Yibai Technology Sarl (281523247)
Establishment
NameAddressID/FEIBusiness Operations
Guangzhou Yibai Technology Sarl281523247manufacture(84315-001)

Revised: 5/2024
Document Id: 17fd3073-2acb-adee-e063-6294a90ae5f5
Set id: 17fd3073-2aca-adee-e063-6294a90ae5f5
Version: 1
Effective Time: 20240508
 
Guangzhou Yibai Technology Sarl