package label

package label
SPL v9
SPL
SPL Set ID 31235a56-b7fc-4d88-83e4-04e61f81be69
Route
topical
Published
Effective Date 2025-12-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

Minoxidil 5% w/w (without propellant)


Medication Information

Warnings and Precautions

For external use only. For use by men only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

Active Ingredient

Minoxidil 5% w/w (without propellant)

Indications and Usage

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

Dosage and Administration

apply half a capful 2 times a day to the scalp in the hair loss area massage into scalp with fingers, then wash hands well see enclosed leaflet for complete directions on how to use 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

Description

Minoxidil 5% w/w (without propellant)

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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. 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.

Section 50569-3

heart disease

Section 50570-1

you are a woman your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Aerosol 5% (Foam) is not intended for frontal baldness or receding hairline. you have no family history of hair loss your 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 on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp

Section 51727-6

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane,lactic acid, polysorbate 60, propane, purified water, SD alcohol,40-Bstearyl alcohol

Section 51945-4

Compare to active ingredient in Men's Rogaine®* EASY-TO-USE MINOXIDIL TOPICAL AEROSOL, 5% (FOAM) FOR MEN HAIR REGROWTH TREATMENT Reactivates hair follicles to stimulate regrowth Easy-to-use form Clinically proven to help regrow hair Unscented NOT FOR USE BY WOMEN 1 CAN 60 g (2.11OZ) *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Men's Rogaine®. DISTRIBUTED BY: RITE AID, 200 NEWBERRY COMMONS ETTERS, PA 17319 www.riteaid.com

Section 53413-1

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 55105-1

Hair regrowth treatment for men

Section 60561-8

hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months see hair loss pictures on side of this carton before use, read all information on carton and enclosed leaflet keep the carton. It contains important information. store at controlled room temperature 20º to 25ºC (68º to 77ºF) contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperature above 120ºF (49ºC).


Structured Label Content

Warnings and Precautions (34071-1)

For external use only. For use by men only. Extremely Flammable: Avoid fire, flame, or smoking during and immediately following application.

Active Ingredient (55106-9)

Minoxidil 5% w/w (without propellant)

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

apply half a capful 2 times a day to the scalp in the hair loss area massage into scalp with fingers, then wash hands well see enclosed leaflet for complete directions on how to use 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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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. 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.

Section 50569-3 (50569-3)

heart disease

Section 50570-1 (50570-1)

you are a woman your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. Minoxidil Topical Aerosol 5% (Foam) is not intended for frontal baldness or receding hairline. you have no family history of hair loss your 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 on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp

Section 51727-6 (51727-6)

butane, butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, isobutane,lactic acid, polysorbate 60, propane, purified water, SD alcohol,40-Bstearyl alcohol

Section 51945-4 (51945-4)

Compare to active ingredient in Men's Rogaine®* EASY-TO-USE MINOXIDIL TOPICAL AEROSOL, 5% (FOAM) FOR MEN HAIR REGROWTH TREATMENT Reactivates hair follicles to stimulate regrowth Easy-to-use form Clinically proven to help regrow hair Unscented NOT FOR USE BY WOMEN 1 CAN 60 g (2.11OZ) *This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., distributor of Men's Rogaine®. DISTRIBUTED BY: RITE AID, 200 NEWBERRY COMMONS ETTERS, PA 17319 www.riteaid.com

Section 53413-1 (53413-1)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Section 55105-1 (55105-1)

Hair regrowth treatment for men

Section 60561-8 (60561-8)

hair growth has been shown in a clinical study of men (mostly white) aged 18-49 years who used it for 4 months see hair loss pictures on side of this carton before use, read all information on carton and enclosed leaflet keep the carton. It contains important information. store at controlled room temperature 20º to 25ºC (68º to 77ºF) contents under pressure. Do not puncture or incinerate container. Do not expose to heat or store at temperature above 120ºF (49ºC).


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