MINOXIDIL 2%- minoxidil lotion MINOXIDIL 5%- minoxidil lotion

Minoxidil 5% by

Drug Labeling and Warnings

Minoxidil 5% by is a Otc medication manufactured, distributed, or labeled by Centro Internacional de Cosmiatría, S.A.P.I. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

Warnings

For external use only

Flammable: Keep away from fire or flame.

Do not use if

your degree of hair loss is different than that shown on the side of this carton, because this product may not work for you
you have no family history of hair loss
your hair loss is sudden and/or patchy
your hair loss is associated with childbirth
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.
your scalp is red, inflamed, infected, irritated, or painful
you use other medicines on the scalp

Ask a doctor before use if you have

Heart disease

When using this product

Do not apply on other parts of the body.
Avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.
Some people have experienced changes in hair color and/or texture.
It takes time to regrow hair. You may need to use this product 2 times a day 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 everyone.

Stop use and ask a doctor if

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 occurs
you do not see hair regrowth in 4 months

May be harmful if used when pregnant or breast-feeding.

DOSAGE & ADMINISTRATION

DIRECTIONS

Before each application, prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist.
Apply 1 mL with sprayer (8 sprays) 2 times a day directly onto the scalp in the hair loss area.
Using more or more often will not improve results.
Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again.

INACTIVE INGREDIENT

ALCOHOL 3K9958V90M 0.25 g IACT
ANHYDROUS CITRIC ACID XF417D3PSL 0.0093 g IACT
BUTYLATED HYDROXYTOLUENE 1P9D0Z171K 0.001 g IACT
PROPYLENE GLYCOL 6DC9Q167V3 0.637 g IACT
WATER 059QF0KO0R 0.0827 g IACT

INDICATIONS & USAGE

Purpose

Hair regrowth treatment.

Use

To regrow hair on the scalp.

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Hair regrowth treatment

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MINOXIDIL 2% 
minoxidil lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77229-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	0.25 g  in 1 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.0093 g  in 1 g
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)	0.001 g  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.637 g  in 1 g
WATER (UNII: 059QF0KO0R)	0.0827 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77229-050-01	1 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/08/2024
2	NDC: 77229-050-13	3 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/08/2024
3	NDC: 77229-050-16	6 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	02/07/2024

MINOXIDIL 5% 
minoxidil lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77229-099
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1)	MINOXIDIL	0.02 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)	0.25 g  in 1 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.0093 g  in 1 g
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)	0.001 g  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.637 g  in 1 g
WATER (UNII: 059QF0KO0R)	0.0827 g  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77229-099-01	1 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/08/2024
2	NDC: 77229-099-13	3 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/08/2024
3	NDC: 77229-099-16	6 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/08/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	02/07/2024

Labeler - Centro Internacional de Cosmiatría, S.A.P.I. de C.V. (814124954)

Establishment
Name	Address	ID/FEI	Business Operations
Centro Internacional de Cosmiatría, S.A.P.I. de C.V.		814124954	manufacture(77229-050, 77229-099)