83596-003

83596-003
SPL v1
SPL
SPL Set ID 15bc9e76-f5c2-9778-e063-6294a90a1136
Route
TOPICAL
Published
Effective Date 2023-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Citric Acid Monohydrate Niacinamide Polysorbate 21 Sodium Lauroyl Sarcosinate Hydrogenated Castor Oil Water Biotin Propylene Glycol Caffeine Collagen Alpha-1(i) Chain Bovine Panthenol Stearyl Alcohol Asian Ginseng

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-19

Description

Minoxidil 5%

Purpose

Hair regrowth treatment for men and women


Medication Information

Purpose

Hair regrowth treatment for men and women

Description

Minoxidil 5%

Use

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

Stop Use

Stop using and ask a doctor if

irritation or allergic reactions develop.

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

Warnings

For external use only. Avoid contact with eyes. If irritation or rash occurs, discontinue use and consult a healthcare professional.

Questions

If you are not satisfied with our product, please contact us at [email protected]. We will do our best to resolve any issues you may have.

Ask Doctor

Stop using and ask a doctor if

irritation or allergic reactions develop.

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

Directions

Apply one milliliter with a dropper for men two times / for women one time a day directly onto the scalp in the hair loss area.

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.

Do Not Use

Do not use it if you are under 18 years of age.

Please do not use it on other parts of the body.

Do not use it if you have no family history of hair loss.

Do not use it if you have a red, inflamed, infected, or painful scalp.

Do not apply to other parts of the body.

Active Ingredient

Minoxidil 5%

Other Information

Store in a cool, dry place, away from direct sunlight.

Inactive Ingredients

Water, Biotin, Propylene Glycol, Citric Acid, Caffeine, Niacinamide, Hydrolyzed Collagen, Polysorbate, Panthenol, Stearyl alcohol, Sodium lauroyl sarcosinate, Ginseng extract, Hydrogenated castor oil

Principal Display Panel

Keep Oot of Reach of Children

Keep out of reach of children.

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)


Structured Label Content

Use

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

Purpose

Hair regrowth treatment for men and women

Stop Use

Stop using and ask a doctor if

irritation or allergic reactions develop.

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

Warnings

For external use only. Avoid contact with eyes. If irritation or rash occurs, discontinue use and consult a healthcare professional.

Questions

If you are not satisfied with our product, please contact us at [email protected]. We will do our best to resolve any issues you may have.

Ask Doctor

Stop using and ask a doctor if

irritation or allergic reactions develop.

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

Directions

Apply one milliliter with a dropper for men two times / for women one time a day directly onto the scalp in the hair loss area.

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.

Do Not Use (Do not use)

Do not use it if you are under 18 years of age.

Please do not use it on other parts of the body.

Do not use it if you have no family history of hair loss.

Do not use it if you have a red, inflamed, infected, or painful scalp.

Do not apply to other parts of the body.

Active Ingredient

Minoxidil 5%

Other Information (Other information)

Store in a cool, dry place, away from direct sunlight.

Inactive Ingredients (Inactive ingredients)

Water, Biotin, Propylene Glycol, Citric Acid, Caffeine, Niacinamide, Hydrolyzed Collagen, Polysorbate, Panthenol, Stearyl alcohol, Sodium lauroyl sarcosinate, Ginseng extract, Hydrogenated castor oil

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Keep out of reach of children.

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)


Advanced Ingredient Data


Raw Label Data

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