Root Activating Shampoo

Root Activating Shampoo
SPL v1
SPL
SPL Set ID 187b815a-32de-af79-e063-6294a90a17b7
Route
TOPICAL
Published
Effective Date 2024-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Polysorbate 80 Panthenol Acetic Acid Propylene Glycol Biotin Niacinamide Water Dimethyl Isosorbide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-15

Description

Minoxidil 5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

ROOT ACTIVATING SHAMPOO STRENGTHEN HAIR ROOT

FORAHELM OF HAIR AS MIGHTY VOLUMINOUS,AND VIGOROUS AS A SPARTA WARRIOL

Dosage and Administration

lt takes time to regrow hair. Results mayoccur at 2 months with once daily use. Forsome individuals, it may take at least 4months before results become noticeable.The amount of hair regrowth is different foreach person. This product will notwork forall women.

Apply 1ml once daily, gently massaging to enhance absorption

Description

Minoxidil 5%

Section 44425-7

Store between 41-86F (5-30 C ). Avoid freezing and exposure to excessiveheat above 104 F(40°C)

Section 50565-1

lf swallowed, get medical help orcontact a Poison Control Center rightaway.(1-800-222-1222)

Section 50566-9

if you experience chest pain, rapidheartbeat, faintness, or dizziness occursScalp irritation or redness occurs. Thesemay be signs of a serious condition.

Section 50567-7

Do not use more than directed.

Avoid contact with the eyes, ears, and mouth.

In case of accidental contactrinse eyeswith large amounts of cool tap water.

Section 50570-1

Your degree of hair loss is different than that shown on side of this carton because this product may not work for you.

Your hair loss is sudden and/or patchy.

You are under 18 years of age. Do not use on babies or children.

Your scalp is red, inflamed, infected.irritated, or painful.

You use other medicines on the scalp.

Section 51727-6

water

biotin

dimethyl isosorbide

acetic acid

panthenol

propylene glycol

niacinamide

polysorbate

Section 51945-4

Section 55105-1

Hair regrowth treatment for women Use to regrow hair on the top of the scalp

Section 55106-9

Minoxidil 5%


Structured Label Content

Indications and Usage (34067-9)

ROOT ACTIVATING SHAMPOO STRENGTHEN HAIR ROOT

FORAHELM OF HAIR AS MIGHTY VOLUMINOUS,AND VIGOROUS AS A SPARTA WARRIOL

Dosage and Administration (34068-7)

lt takes time to regrow hair. Results mayoccur at 2 months with once daily use. Forsome individuals, it may take at least 4months before results become noticeable.The amount of hair regrowth is different foreach person. This product will notwork forall women.

Apply 1ml once daily, gently massaging to enhance absorption

Warnings and Precautions (34071-1)

For external use only

Section 44425-7 (44425-7)

Store between 41-86F (5-30 C ). Avoid freezing and exposure to excessiveheat above 104 F(40°C)

Section 50565-1 (50565-1)

lf swallowed, get medical help orcontact a Poison Control Center rightaway.(1-800-222-1222)

Section 50566-9 (50566-9)

if you experience chest pain, rapidheartbeat, faintness, or dizziness occursScalp irritation or redness occurs. Thesemay be signs of a serious condition.

Section 50567-7 (50567-7)

Do not use more than directed.

Avoid contact with the eyes, ears, and mouth.

In case of accidental contactrinse eyeswith large amounts of cool tap water.

Section 50570-1 (50570-1)

Your degree of hair loss is different than that shown on side of this carton because this product may not work for you.

Your hair loss is sudden and/or patchy.

You are under 18 years of age. Do not use on babies or children.

Your scalp is red, inflamed, infected.irritated, or painful.

You use other medicines on the scalp.

Section 51727-6 (51727-6)

water

biotin

dimethyl isosorbide

acetic acid

panthenol

propylene glycol

niacinamide

polysorbate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Hair regrowth treatment for women Use to regrow hair on the top of the scalp

Section 55106-9 (55106-9)

Minoxidil 5%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)