87086-001 Carenice 5% Minoxidil Hair Regrowth Treatment

87086-001 Carenice 5% Minoxidil Hair Regrowth Treatment
SPL v1
SPL
SPL Set ID 3e4254d1-a0ce-a347-e063-6294a90a9d92
Route
TOPICAL
Published
Effective Date 2025-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Phenoxyethanol Stearic Acid Camellia Sinensis Leaf Glycerin Propane Isobutane Lactic Acid Butane Polysorbate 20 Platycladus Orientalis Whole Water Purslane Alcohol Propylene Glycol Cetearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-08

Description

MINOXIDIL 5%


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.

Indications and Usage

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

Dosage and Administration



1:PREP HANDSWITHCOLD WATER

Rinse your fingers in cold water and dry them.

Note: foam will melt oncontact with warmsurfaces.

2:OPEN THE CAP

Hold the bottle with one hand and the lid with the other, then pull it open with force.

3:DISPENSE VERTICALLYONTO A COLD SURFACE

Hold the can straight

upside down. lf you hold the can at an angle, foam may not dispense properly.Press nozzle to dispense half a capful of foam onto cold surface (e.g. dish, or cold hands).

4: APPLY TO SCALPNOT HAIR

Part your hair to expose hair loss area. Massage foam into scalp, not hair.Repeat until all hair loss areas have been covered.

5:CLOSE CAP ANDWASH HANDS

Snap cap back into place.Be sure arrows do not line up, so cap remains child resistant.Wash hands and any surface thoroughly after use.

Description

MINOXIDIL 5%

Section 50565-1

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

Section 50566-9



Chest paint,rapid heartbeat,faintness,or dizziness occurs.

Sudden,unexplained weight gain occurs your hands or fee swell

Scalp irritation or redness occurs.

Unwanted facial hair growth occurs.

Section 50567-7



Increased hair loss may occur in the early stages of use(2-4 weeks) (activation period of hair follicles), which is anormalohenomenon.

Do not use more than directed.

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.

Effects: Some people may experience dryness and itching of the scalp. In such cases, reduce the dosage or consult a doctor

Section 50570-1



You are a woman

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

Inactive ingredients : isobutane, propane, alcohol, butane,glycerin, propyleneglycol, sttearic acid, cetearyl alcohol,polysorbate 20, lactic acid, phenoxyethanol, biota orientalis,leafextract, portulaca oleracea extract, purified water.

Section 51945-4

Section 55105-1

Hair regrowth treatment

Section 55106-9

MINOXIDIL 5%


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)



1:PREP HANDSWITHCOLD WATER

Rinse your fingers in cold water and dry them.

Note: foam will melt oncontact with warmsurfaces.

2:OPEN THE CAP

Hold the bottle with one hand and the lid with the other, then pull it open with force.

3:DISPENSE VERTICALLYONTO A COLD SURFACE

Hold the can straight

upside down. lf you hold the can at an angle, foam may not dispense properly.Press nozzle to dispense half a capful of foam onto cold surface (e.g. dish, or cold hands).

4: APPLY TO SCALPNOT HAIR

Part your hair to expose hair loss area. Massage foam into scalp, not hair.Repeat until all hair loss areas have been covered.

5:CLOSE CAP ANDWASH HANDS

Snap cap back into place.Be sure arrows do not line up, so cap remains child resistant.Wash hands and any surface thoroughly after use.

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.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)



Chest paint,rapid heartbeat,faintness,or dizziness occurs.

Sudden,unexplained weight gain occurs your hands or fee swell

Scalp irritation or redness occurs.

Unwanted facial hair growth occurs.

Section 50567-7 (50567-7)



Increased hair loss may occur in the early stages of use(2-4 weeks) (activation period of hair follicles), which is anormalohenomenon.

Do not use more than directed.

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.

Effects: Some people may experience dryness and itching of the scalp. In such cases, reduce the dosage or consult a doctor

Section 50570-1 (50570-1)



You are a woman

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)

Inactive ingredients : isobutane, propane, alcohol, butane,glycerin, propyleneglycol, sttearic acid, cetearyl alcohol,polysorbate 20, lactic acid, phenoxyethanol, biota orientalis,leafextract, portulaca oleracea extract, purified water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair regrowth treatment

Section 55106-9 (55106-9)

MINOXIDIL 5%


Advanced Ingredient Data


Raw Label Data

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