NDC 70150-003 Ext Hair Regrowth Treatment For Men 5%

Minoxidil 5%

NDC Product Code 70150-003

NDC 70150-003-01

Package Description: 1 BOTTLE in 1 BOX > 60 mL in 1 BOTTLE

NDC Product Information

Ext Hair Regrowth Treatment For Men 5% with NDC 70150-003 is a a human over the counter drug product labeled by Ttem, Llc. The generic name of Ext Hair Regrowth Treatment For Men 5% is minoxidil 5%. The product's dosage form is solution and is administered via topical form.

Labeler Name: Ttem, Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ext Hair Regrowth Treatment For Men 5% Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • MINOXIDIL 5 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ttem, Llc
Labeler Code: 70150
FDA Application Number: ANDA076239 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-10-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Ext Hair Regrowth Treatment For Men 5% Product Label Images

Ext Hair Regrowth Treatment For Men 5% Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Minoxidil 5% w/v

Otc - Purpose

Hair regrowth treatment for men

Use

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

Warnings

WarningsFor external use onlyFlammable: Keep away from fire or flame

Otc - Do Not Use

Do not use if■ you are a woman ■ your amount of hair loss is dierent than thatshown on the side of this carton, or your hair loss is on the front of thescalp. EXT Hair Regrowth Treatment is not intended for frontal baldnessor receding hairline. ■ you have no family history of hair loss ■ yourhair loss is sudden and/or patchy ■ you do not know the reason foryour hair loss ■ you are under 18 years of age. Do not use on babiesand children. ■ your scalp is red, inflamed, infected, irritated, or painful■ you use other medicines on the scalp

Otc - Ask Doctor

Ask a doctor before use if you have heart disease

Otc - 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 eyeswith large amounts of cool tap water.■ some people have experienced changes in hair color and/or texture■ it takes time to regrow hair. Results may occur at 2 months withtwice a day usage. For some men, you may need to use this productfor at least 4 months before you see results.■ the amount of hair regrowth is different for each person. Thisproduct will not work for everyone.

Otc - Stop Use

Stop use and ask a doctor if■ side eects occur. You may report side eects to FDA at1.800.FDA.1088■ chest pain, rapid heartbeat, faintness, or dizziness occurs ■ sudden,unexplained weight gain occurs ■ your hands or feet swell ■ scalpirritation or redness occurs ■ unwanted facial hair growth occurs ■you do not see hair regrowth in 4 months

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

Directions

Directions■ apply one mL with dropper 2 times a day directly onto the scalp inthe area of hair loss■ 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.

Other Safety Information

Other information■ see hair loss pictures on side of this carton■ before use, read all information on carton and enclosed leaflet■ keep this carton. It contains important information.■In an observational study of 733 male subjects, more than 63% ofparticipants found EXT Hair Regrowth Treatment to be eective or veryeective in hair regrowth.■ store at controlled room temperature between 68° - 77°F(20°-25°C). Keep tightly closed.

Inactive Ingredient

Inactive ingredientsalcohol, propylene glycol, purified water

* Please review the disclaimer below.