SUNHEAL 5% MINOXIDIL HAIR GROWTH FOAM- sunheal 5% minoxidil hair growth foam aerosol, foam 
Eubizrival LLC

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83462-022

Active Ingredient

Minoxidil 5% w/w

Purpose

Hair regrowth treatment

Use

to regrow hair on the scalp

Warnings

For external use only.

Do not use

■no one in your family has hair loss, but if you have hair loss is sudden or patchy or both.
■you don't know why your hair is falling out.
■you are under 18 years of age. Do not use it on babies and children.
■the scalp becomes red, inflamed, infected, inflamed, and painful.
■you are using other medicines on your scalp.

Stop Use

■Chest pain, rapid heart rate, fainting, and dizziness may occur.
■Sudden, unexplained weight gain.
■Your hands or feet swell
■Inflammation and redness of the scalp occur
■Unwanted hair grows on your face. After 4 months, the hair will stop growing.

Ask Doctor

■Chest pain, rapid heart rate, fainting, and dizziness may occur.
■Sudden, unexplained weight gain.
■Your hands or feet swell
■Inflammation and redness of the scalp occur
■Unwanted hair grows on your face. After 4 months, the hair will stop growing.

Keep Oot Of Reach Of Children

If swallowed, get medical help or contact a poison control center right away.

Directions

■Apply 1 pump of foam directly from the back of the crown to the frontal region.
■After massaging the scalp with your fingertips, wash your hands thoroughly. Using more of the hair growth foam or using it more often does not improve the results.
■Continued use is required to increase and maintain hair regrowth.
■Discontinuation may lead to hair loss.

Other information

■Read all information on pack before use.
■Save the box. Contains important information.
■Store at controlled room temperature 20-25°C (68-77°F).
■Content under pressure. Do not puncture or burn container. Do not expose to heat or store above 120°F (9°C).

Inactive ingredients

Biotin, Water, Propylene Glycol, Dimethyl Isosorbide, Acetic Acid, Panthenol, Niacinamide, Polysorbate 20, Sodium Lauroyl Sarcosinate, Aloe Barbadensis Flower Extract, PEG-50 Hydrogenated Castor Oil, Perfume, Hydrolyzed Collagen

PRINCIPAL DISPLAY PANEL

1

SUNHEAL 5% MINOXIDIL HAIR GROWTH FOAM 
sunheal 5% minoxidil hair growth foam aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83462-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PANTHENOL (UNII: WV9CM0O67Z)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALOE VERA FLOWER (UNII: 575DY8C1ER)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
ACETIC ACID (UNII: Q40Q9N063P)  
POLYOXYL 50 HYDROGENATED CASTOR OIL (UNII: R07D3A9614)  
HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P)  
BIOTIN (UNII: 6SO6U10H04)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
NIACINAMIDE (UNII: 25X51I8RD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83462-022-0160 g in 1 BOTTLE; Type 0: Not a Combination Product11/03/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20907411/03/2023
Labeler - Eubizrival LLC (036572203)
Establishment
NameAddressID/FEIBusiness Operations
Eubizrival LLC036572203label(83462-022) , manufacture(83462-022)

Revised: 4/2024
Document Id: 1639e05e-24be-475e-e063-6394a90a8296
Set id: 1639e41c-8b31-ff77-e063-6294a90a13a6
Version: 1
Effective Time: 20240416
 
Eubizrival LLC