5% Minoxidil Serum by Consilii LLC 83299-018 Completed

5% Minoxidil Serum by

Drug Labeling and Warnings

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

Drug Details [pdf]

5% MINOXIDIL SERUM- 5% minoxidil serum liquid 
Consilii LLC

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83299-018 Completed

Active Ingredient

Minoxidil 5%

Purpose

Hair Regrowth Treatment

Use

to regrow hair on the top of the scalp

Warnings

For external use only

For use on the scalp only

Avoid contact with eyes

Keep out of reach of children

Keep stored at room temperature

Do not use

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

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

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

Sterilize the roller with alcohol before use

Clean the skin area and dry it

Apply roller gently on your skin, roll diagnoally, horizontally & vertically 4-5 times on target areas

Apply 2-3 drops of serum directly to the scalp in the area to be treated

Massage into the scalp with your finger then wash hand thoroughly

Always perform the test on a small area of the skin to make sure there is no allergic reaction

Initial shedding may occur as the new hairs push out older strands.

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

mesandycare@gmail.com

PRINCIPAL DISPLAY PANEL

5% MINOXIDIL SERUM 
5% minoxidil serum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83299-018
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BIOTIN (UNII: 6SO6U10H04)
.GAMMA.-AMINOBUTYRIC ACID (UNII: 2ACZ6IPC6I)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83299-018-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075357	10/31/2023	08/29/2024

Labeler - Consilii LLC (118891890)

Establishment
Name	Address	ID/FEI	Business Operations
Consilii LLC		118891890	label(83299-018) , manufacture(83299-018)

Revised: 8/2024

Document Id: 20d18061-8168-9c12-e063-6394a90a1ff9

34390-5

Set id: 090e409a-4264-dfc6-e063-6294a90aea91

Version: 2

Effective Time: 20240829

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