SPL v1
SPL
SPL Set ID e642a352-4387-404d-b090-789687884b9e
Route
TOPICAL
Published
Effective Date 2019-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (50 mg)
Inactive Ingredients
Azelaic Acid Retinol Caffeine Biotin Saw Palmetto Urtica Dioica Pygeum Water Alcohol Propylene Glycol Dimethyl Isosorbide Agave Tequilana Leaf Zinc Sulfate Pyridoxine

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2019-03-01

Description

Minoxidil 5%


Medication Information

Warnings and Precautions

For external use only. 

Flammable: Keep away from fire or flame

Do not use if:

• You have no family history of hair loss

• Your hair loss is sudden and/or patchy

• Your hair loss is associated with childbirth

• 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, irritated or painful

• You use other medicines on the scalp

Ask a doctor before use if you have heart disease

When using this product

• 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 tap water

• Some people have experienced changes in hair color and/or texture    it takes time to regrow hair. 

• You may need to use this product 2 times a day for at least 4 months before you see results

• The amount of hair regrowth is different for each person.

• This product may not work for everyone.

Stop use and/or ask a doctor if

• Chest pain, rapid heartbeat, faintness, dizziness or 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

May be harmful is used when pregnant or breast-feeding.

Indications and Usage

Description

Minoxidil 5%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 53413-1

Questions or comments:

1-281-454-3563

Section 55105-1

Hair Regrowth Treatment for Men

Section 55106-9

Minoxidil 5%

Directions

Using dropper, apply one mL directly onto the scalp in the hair loss area

For best results use twice daily on dry towel dried hair.

Use fingertips to massage solution into skin

Other Information

• Store at controlled room temperature 68º to 77ºF (20º- 25ºC)

Other Ingredients

Azelaic Acid, Retinol, Caffeine, Biotin, Saw Palmetto Extract, Nettle Extract 10:1, Pygeum Bark Extract, Water, SD Alcohol, Propylene Glycol, Gransolve DMI, Fresh Blue Agave, Zinc Sulfate, Vitamin B6.

Principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

Warnings and Precautions (34071-1)

For external use only. 

Flammable: Keep away from fire or flame

Do not use if:

• You have no family history of hair loss

• Your hair loss is sudden and/or patchy

• Your hair loss is associated with childbirth

• 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, irritated or painful

• You use other medicines on the scalp

Ask a doctor before use if you have heart disease

When using this product

• 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 tap water

• Some people have experienced changes in hair color and/or texture    it takes time to regrow hair. 

• You may need to use this product 2 times a day for at least 4 months before you see results

• The amount of hair regrowth is different for each person.

• This product may not work for everyone.

Stop use and/or ask a doctor if

• Chest pain, rapid heartbeat, faintness, dizziness or 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

May be harmful is used when pregnant or breast-feeding.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 53413-1 (53413-1)

Questions or comments:

1-281-454-3563

Section 55105-1 (55105-1)

Hair Regrowth Treatment for Men

Section 55106-9 (55106-9)

Minoxidil 5%

Directions

Using dropper, apply one mL directly onto the scalp in the hair loss area

For best results use twice daily on dry towel dried hair.

Use fingertips to massage solution into skin

Other Information

• Store at controlled room temperature 68º to 77ºF (20º- 25ºC)

Other Ingredients

Azelaic Acid, Retinol, Caffeine, Biotin, Saw Palmetto Extract, Nettle Extract 10:1, Pygeum Bark Extract, Water, SD Alcohol, Propylene Glycol, Gransolve DMI, Fresh Blue Agave, Zinc Sulfate, Vitamin B6.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)