5% MINOXIDIL SPRAY.- 5% minoxidil spray spray 
Consilii LLC

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83299-021

Active Ingredient

Minoxidil 5%

Purpose

Hair Regrowth Treatment

Use

to regrow hair on the top of the scalp

Warnings

For external use only

Keep away from fire and flame

Avoid contact with eyes

Do not use

You have no family history of hair loss,hair loss is sudden and/or patchy

you are under 18 years of age.Do not use it on babies and children

When Using

Do not apply on other parts of the body

void contact with eyes. In case of accidental contact, rinse eyes with a large amount of cool tap water

It takes time to regrow hair. You may need to use this product 2 times a day for a least 4 months before you see results, The amount of hair regrowth is different for each person

Stop Use

chest pain, rapid heart beat, faintness, or dizziness occurs

sudden, unexplained weight gain occurs

your hands or feet swell

scalp irritation or redness occurs

Ask Doctor

When Pregnant or breast-feeding

Keep Oot Of Reach Of Children

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

Directions

Apply 1ml(5 Sprays) twice a day.Once in the morning and another time in the evening before bed

Spray directly on top of the scalp in the area to be treated

Discontinuing use may result in hair loss

Other information

Before use, read all information on the carton

Store at controlled room temperature 20 to 25 C (68 to 77°F)

Inactive ingredients

Deionized Water,Propylene Glycol,Ethyl Alcohol,Potassium Sorbate,GABA

Questions

Tomumcs@gmail.com

PRINCIPAL DISPLAY PANEL

01

5% MINOXIDIL SPRAY. 
5% minoxidil spray spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83299-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1) MINOXIDIL5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
.GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83299-021-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product10/07/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)10/07/2023
Labeler - Consilii LLC (118891890)
Establishment
NameAddressID/FEIBusiness Operations
Consilii LLC118891890label(83299-021) , manufacture(83299-021)

Revised: 4/2024
Document Id: 15bdf9c6-3bfb-4eef-e063-6294a90a195f
Set id: 15bddf2b-c4ec-4503-e063-6294a90a0562
Version: 1
Effective Time: 20240410
 
Consilii LLC