Happy Head Womens Hair Regrowth Treatment MINOXIDIL HAPPY HEAD, INC FDA Approved Use to regrow hair on the scalp
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Substance Minoxidil
Route
TOPICAL
Applications
ANDA078176
Product NDC
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Minoxidil 2% w/v Purpose Hair regrowth treatment for women
Inactive Ingredients
Inactive ingredients Alcohol Propylene Glycol Purified Water
Strengths
2 %
Treats Conditions
Use To Regrow Hair On The Scalp

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0860010222164
UNII
5965120SH1
Packaging

Package Labeling: Outer Package Inner Package Box Box2

Package Descriptions
  • Package Labeling: Outer Package Inner Package Box Box2

Overview

Use to regrow hair on the scalp

Indications & Usage

Use to regrow hair on the scalp

Dosage & Administration

Directions • apply one mL with dropper 2 times 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

Warnings & Precautions
Warnings For external use only. Flammable : Keep away from fire or flame Do not use if: • your amount of hair loss is different than that shown on the side of this carton, because this product may not work for you • 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, infected, 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 cool 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 will not work for all women. Stop use and ask a doctor if • 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 May be harmful if used when pregnant or breast-feeding. Keep out of reach of children. If swallowed, get medical help, or contact a Poison Control Center right away.
Purpose

Purpose Hair regrowth treatment for women

Do Not Use

Do not use if: • your amount of hair loss is different than that shown on the side of this carton, because this product may not work for you • 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, infected, irritated, or painful • you use other medicines on the scalp

When Using

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 cool 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 will not work for all women.

Stop Use & Ask a Doctor

Stop use and ask a doctor if • 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

Keep Out of Reach of Children

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

Questions

Questions or comments? 1-844-962-4247 Visit Website at www.happyhead.com/help


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