​83809-013-01

​83809-013-01
SPL v1
SPL
SPL Set ID 0c4ba5e3-24ac-b05a-e063-6394a90aab67
Route
TOPICAL
Published
Effective Date 2023-12-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Minoxidil (5 g)
Inactive Ingredients
Potassium Sorbate .gamma.-aminobutyric Acid Chamomile Water Lavender Oil Cymbopogon Citratus Leaf Propylene Glycol Rose Oil Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-04

Description

Minoxidil 5%

Purpose

Hair Regrowth Treatment


Medication Information

Purpose

Hair Regrowth Treatment

Description

Minoxidil 5%

Use

Use to regrow hair on the top of the scalp

Stop Use

-chest pain, rapid heart beat.faintness, or dizziness occurs sudden, unexplained weight gain occurs.

-your hands or feet swell scalp imitation or redness occurs

-May be harmful if used when pregnant or breast-feeding

-Keep Out Of Reach Of Chlidren: if swallowed,get medical help or contact a Poison Control Center right away.

Warnings

-For external use only

-Keep away from fire and flame

Directions

-Apply twice a day. Once in the morning and another time in the evening before bed

-Spray directly on top of the scalp in the area to be treated

-Using more than directed or more often will not improve results

-Continued use is necessary to lncrease and then malntain your hair regrowth

-Discontinuing use may result in hair loss

Do Not Use

-You have no family history of hair loss,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 it on bables and children your scalp is red.inflamed,infected, imitated,or painful.

-You use other medicines on the scalp

-Ask a Doctor before use of you have Heart disease.

When Using

-Do not apply to other parts of the body. void contact with eyes.In case of accidental contact,rinse eyes with a large amount of cool tap water.

-It takes time to regrow hair.You may need to use this product 2 times a day for a least 4 months before you see results,The amount of hair regrowth is different for each person

Active Ingredient

Minoxidil 5%

Inactive Ingredients

Deionized Water,propylene Glycol,potassium Sorbate,Castor Oil,lavender Oil, Cymbopogon Citratus Leaf, Chamomile, Rosa Oil, Gaba

Principal Display Panel

Keep Oot of Reach of Children

Keep Out Of Reach Of Chlidren


Structured Label Content

Use

Use to regrow hair on the top of the scalp

Purpose

Hair Regrowth Treatment

Stop Use

-chest pain, rapid heart beat.faintness, or dizziness occurs sudden, unexplained weight gain occurs.

-your hands or feet swell scalp imitation or redness occurs

-May be harmful if used when pregnant or breast-feeding

-Keep Out Of Reach Of Chlidren: if swallowed,get medical help or contact a Poison Control Center right away.

Warnings

-For external use only

-Keep away from fire and flame

Directions

-Apply twice a day. Once in the morning and another time in the evening before bed

-Spray directly on top of the scalp in the area to be treated

-Using more than directed or more often will not improve results

-Continued use is necessary to lncrease and then malntain your hair regrowth

-Discontinuing use may result in hair loss

Do Not Use (Do not use)

-You have no family history of hair loss,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 it on bables and children your scalp is red.inflamed,infected, imitated,or painful.

-You use other medicines on the scalp

-Ask a Doctor before use of you have Heart disease.

When Using

-Do not apply to other parts of the body. void contact with eyes.In case of accidental contact,rinse eyes with a large amount of cool tap water.

-It takes time to regrow hair.You may need to use this product 2 times a day for a least 4 months before you see results,The amount of hair regrowth is different for each person

Active Ingredient

Minoxidil 5%

Inactive Ingredients (Inactive ingredients)

Deionized Water,propylene Glycol,potassium Sorbate,Castor Oil,lavender Oil, Cymbopogon Citratus Leaf, Chamomile, Rosa Oil, Gaba

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Keep Out Of Reach Of Chlidren


Advanced Ingredient Data


Raw Label Data

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