84249-001

84249-001
SPL v1
SPL
SPL Set ID 15a26123-4f70-4be4-e063-6294a90ad099
Route
TOPICAL
Published
Effective Date 2024-04-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Castor Oil Alcohol Biotin Niacinamide Water Rosemary Oil Aloe Vera Leaf Glycerin Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-08

Description

Minoxidil 5% w/w

Purpose

Hair or beard regrowth treatment


Medication Information

Purpose

Hair or beard regrowth treatment

Description

Minoxidil 5% w/w

Stop Use

chest pain, rapid heartbeat, faintness, or dizziness occurs

sudden,unexplained weight gain occurs

your hands or feet swell

skin imitation or redness occurs

you do not see hair or beard regrowth in 4 months

Warnings

For external use only

Ask Doctor

chest pain, rapid heartbeat, faintness, or dizziness occurs

sudden,unexplained weight gain occurs

your hands or feet swell

skin imitation or redness occurs

you do not see hair or beard regrowth in 4 months

Directions

apply 1ml(5 sprays) twice a day directly to the roots of the hair or beard loss area

Do Not Use

you do not know the reason for your hair or beard loss

you are under 18 years of age.Do not use on babies and children

your under hair or beard skin is red,inflamed,infected,imitated or painful

you use other medicines on your under hair or beard skin

When Using

do not apply on other parts of the body, except the hair or beard

avoid contact with the eyes. In case of accidental contact, rinse eyes with large amount of cool tap water

it takes time to regrow hair. Results may occur at 4 months with continuous usage

the amount of hair or beard regrowth is different for each person. This product will not work for all men

Active Ingredient

Minoxidil 5% w/w

Other Information

store at 20-25℃(68-77°F)

Inactive Ingredients

Aloe Vera Extract,Biotin, Castor Oil,Deionized Water,Ethanol, Glycerin, Niacinamide, Panthenol,,Rosemary Oil.

Principal Display Panel

Keep Oot of Reach of Children

If swallowed,get medical help or contact a Poison Control Center right away


Structured Label Content

Purpose

Hair or beard regrowth treatment

Stop Use

chest pain, rapid heartbeat, faintness, or dizziness occurs

sudden,unexplained weight gain occurs

your hands or feet swell

skin imitation or redness occurs

you do not see hair or beard regrowth in 4 months

Warnings

For external use only

Ask Doctor

chest pain, rapid heartbeat, faintness, or dizziness occurs

sudden,unexplained weight gain occurs

your hands or feet swell

skin imitation or redness occurs

you do not see hair or beard regrowth in 4 months

Directions

apply 1ml(5 sprays) twice a day directly to the roots of the hair or beard loss area

Do Not Use (Do not use)

you do not know the reason for your hair or beard loss

you are under 18 years of age.Do not use on babies and children

your under hair or beard skin is red,inflamed,infected,imitated or painful

you use other medicines on your under hair or beard skin

When Using

do not apply on other parts of the body, except the hair or beard

avoid contact with the eyes. In case of accidental contact, rinse eyes with large amount of cool tap water

it takes time to regrow hair. Results may occur at 4 months with continuous usage

the amount of hair or beard regrowth is different for each person. This product will not work for all men

Active Ingredient

Minoxidil 5% w/w

Other Information (Other information)

store at 20-25℃(68-77°F)

Inactive Ingredients (Inactive ingredients)

Aloe Vera Extract,Biotin, Castor Oil,Deionized Water,Ethanol, Glycerin, Niacinamide, Panthenol,,Rosemary Oil.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If swallowed,get medical help or contact a Poison Control Center right away


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)