5% Minoxidil Topical Aerosol

5% Minoxidil Topical Aerosol
SPL v1
SPL
SPL Set ID 3514a9f1-d343-9312-e063-6394a90ac16c
Route
TOPICAL
Published
Effective Date 2025-05-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g) Caffeine (0.2 g) Niacinamide (0.3 g) Biotin
Inactive Ingredients
Glycerin Propylene Glycol Aqua Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-14

Description

Minoxidil 5% Biotin 0.3% Niacinamide 0.2% Caffeine 0.2%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Use to Regrow Hair on Scalpand Beard

Dosage and Administration



Apply half a capful twice a day to thescalp in the hair loss area. Massageinto the scalp with fingers, then washhands well.

Using more or more often will notimprove results. Continued use isnecessary to increase and maintainhair regrowth, otherwise, hair loss willbegin again.

Complete instructions on howto use and get the best results.

1: PREP HANDS WITH COLD WATERRinse your fingers in cold water anddry them. Note: Foam will melt oncontact with warm surfaces

2: OPEN THE BOTTLE SAFETY CAPAfter opening the cap, shake the canvigorously to ensure the liquid is fullydistributed.

3: DISPENSE VERTICALLY ONTO ACOLD SURFACEHold the can straight upside down. lfyou hold the can at an angle, the foammay not dispense properly. Press thenozzle to dispense half a capful offoam onto a cold surface (e.g., dish orcold hands).

4: APPLY TO SCALP, NOT HAIRPart your hair to expose the hair lossarea. Massage the foam into your scalp,not your hair. Repeat until all hair lossareas have been covered.

5: CLOSE CAP AND WASH HANDSReplace the cap, making sure it issecurely closed and out of the reach ofchildren. Wash hands and any surfacesthoroughly after use.

Description

Minoxidil 5% Biotin 0.3% Niacinamide 0.2% Caffeine 0.2%

Section 50565-1

Keep out ofreach of children.

Section 50566-9

Discontinue use if any irritation oradverse reaction occurs.

Section 50567-7

Avoid contactwith eyes.

If you are pregnant, nursing, or haveany underlying medical conditions,consult your healthcare providerbefore using the product.

Section 50570-1

Do not use on broken or irritated scalp

Section 51727-6

Aqua (Water)

Alcohol

Glycerin

Propylene Glycol

Section 51945-4

Section 55105-1

Hair regrowth treatment

Anti-hair loss

Helps hair regrowth

Anti-hair loss

Section 55106-9

Minoxidil 5%

Biotin 0.3%

Niacinamide 0.2%

Caffeine 0.2%


Structured Label Content

Indications and Usage (34067-9)

Use to Regrow Hair on Scalpand Beard

Dosage and Administration (34068-7)



Apply half a capful twice a day to thescalp in the hair loss area. Massageinto the scalp with fingers, then washhands well.

Using more or more often will notimprove results. Continued use isnecessary to increase and maintainhair regrowth, otherwise, hair loss willbegin again.

Complete instructions on howto use and get the best results.

1: PREP HANDS WITH COLD WATERRinse your fingers in cold water anddry them. Note: Foam will melt oncontact with warm surfaces

2: OPEN THE BOTTLE SAFETY CAPAfter opening the cap, shake the canvigorously to ensure the liquid is fullydistributed.

3: DISPENSE VERTICALLY ONTO ACOLD SURFACEHold the can straight upside down. lfyou hold the can at an angle, the foammay not dispense properly. Press thenozzle to dispense half a capful offoam onto a cold surface (e.g., dish orcold hands).

4: APPLY TO SCALP, NOT HAIRPart your hair to expose the hair lossarea. Massage the foam into your scalp,not your hair. Repeat until all hair lossareas have been covered.

5: CLOSE CAP AND WASH HANDSReplace the cap, making sure it issecurely closed and out of the reach ofchildren. Wash hands and any surfacesthoroughly after use.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out ofreach of children.

Section 50566-9 (50566-9)

Discontinue use if any irritation oradverse reaction occurs.

Section 50567-7 (50567-7)

Avoid contactwith eyes.

If you are pregnant, nursing, or haveany underlying medical conditions,consult your healthcare providerbefore using the product.

Section 50570-1 (50570-1)

Do not use on broken or irritated scalp

Section 51727-6 (51727-6)

Aqua (Water)

Alcohol

Glycerin

Propylene Glycol

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair regrowth treatment

Anti-hair loss

Helps hair regrowth

Anti-hair loss

Section 55106-9 (55106-9)

Minoxidil 5%

Biotin 0.3%

Niacinamide 0.2%

Caffeine 0.2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)