5% Minoxidil Spray. by Consilii LLC 83299-020 Completed

5% Minoxidil Spray. by

Drug Labeling and Warnings

5% Minoxidil Spray. by is a Otc medication manufactured, distributed, or labeled by Consilii LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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83299-020 Completed

Active Ingredient

Minoxidil 5%

Purpose

Hair Regrowth Treatment

Use

to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)

Warnings

For external use only

For use by men only

Do not use

your amount of hair loss is different than that shown on side of this carton, or your hair loss is on the front of the scalp. Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.
you have no family history of hair loss

You have no family history of hair loss,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 it on babies and children

scalp is red,inflamed,infected,irritated,or painful

you use other medicines on th scalp

When Using

Do not apply on other parts of the body

avoid contact with eyes. In case of accidental contact, rinse eyes with a large amount 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 men, 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 not work for all men.

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

unwanted facial hair growth occurs

you do not see hair regrowth in 4 months

Ask Doctor

When Pregnant or breast-feeding

If you have heart desease

Keep Oot Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply 5 sprays 2 times a day directly to the scalp in the hair loss area

Using more than directed or more often will not improve results.

Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Other information

see hair loss pictures on side of this carton

Before use, read all information on the carton

keep the carton.It contains important information.

hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with minoxidil topical aerosol 5% for men

in clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, minoxidil topical aerosol 5% for men provided more hair regrowth than minoxidil topical aerosol 2%

Store at 20 to 25°C (68 to 77°F). Keep tightly closed.

Inactive ingredients

Deionized Water,Biotin, Rosemary Oil, Castor Oil, Panthenol, Niacinamide, Aloe Vera Extract, Ethanol, Glycerin

Questions

customerservice@avitapure.com

PRINCIPAL DISPLAY PANEL

0102

5% MINOXIDIL SPRAY. 
5% minoxidil spray liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 83299-020
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)  
CASTOR OIL (UNII: D5340Y2I9G)  
WATER (UNII: 059QF0KO0R)  
BIOTIN (UNII: 6SO6U10H04)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PANTHENOL (UNII: WV9CM0O67Z)  
NIACINAMIDE (UNII: 25X51I8RD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 83299-020-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product11/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07535711/01/202308/29/2024
Labeler - Consilii LLC (118891890)
Establishment
NameAddressID/FEIBusiness Operations
Consilii LLC118891890label(83299-020) , manufacture(83299-020)

Revised: 8/2024
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