5% Minoxidil hair growth oil by Consilii LLC 83299-017 Completed

5% Minoxidil hair growth oil by

Drug Labeling and Warnings

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

Drug Details [pdf]

5% MINOXIDIL HAIR GROWTH OIL- 5% minoxidil hair growth oil liquid 
Consilii LLC

----------

83299-017 Completed

Active Ingredient

Minoxidil 5%

Purpose

Use

to regrow hair on the scalp

Warnings

For external use only.

Do not use

Pregnant, Feeding, Heart sensibility, Super-sensitive skin, an open wound since that can cause irritations.
Scalp is red, inflamed, infected, irritated, or painful.
You use other medicines on the 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.
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.
The product will not work for everyone.

Stop Use

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 develops.
No hair regrowth is seen in 4 months.

Ask Doctor

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 develops.
No hair regrowth is seen in 4 months.

Keep Oot Of Reach Of Children

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

Directions

Apply 2-4 drops directly to the treated scalp area.
Massage into the scalp and wash hands thoroughly.
Visible results may take 2 months with twice-daily application. For some, at least 4 months of use may be needed.Effectiveness varies.

Other information

Before use, read all information on the carton.
Store at a controlled room temperature of 20 to 25°C (68 to 77°F).
Contents under pressure. Do not puncture or incinerate the container. Do not expose to heat or store at temperatures above 120°F (49 °C).

Inactive ingredients

AQUA、NIACINAMIDE、GLYCERIN、PROPYLENE GLYCOL、CARNITINE、ACETYL TETRAPEPTIDE-3

Questions

venanocics@gmail.com

PRINCIPAL DISPLAY PANEL

5% MINOXIDIL HAIR GROWTH OIL 
5% minoxidil hair growth oil liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83299-017
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
ACETYL TETRAPEPTIDE-3 (UNII: D1HW9N9QBX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARNITINE (UNII: S7UI8SM58A)
WATER (UNII: 059QF0KO0R)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83299-017-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2023

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

Labeler - Consilii LLC (118891890)

Establishment
Name	Address	ID/FEI	Business Operations
Consilii LLC		118891890	label(83299-017) , manufacture(83299-017)

Revised: 8/2024

Document Id: 20d16952-4a40-f5b8-e063-6394a90a65b1

34390-5

Set id: 0744812f-73e4-14b9-e063-6394a90ada09

Version: 2

Effective Time: 20240829

 <