NDC 70150-005 Rootly Extra Strength Hair Regrowth Treatment For Men

Minoxidil 5%

NDC Product Code 70150-005

NDC CODE: 70150-005

Proprietary Name: Rootly Extra Strength Hair Regrowth Treatment For Men What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Minoxidil 5% What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 70150 - Ttem, Llc
    • 70150-005 - Rootly Extra Strength Hair Regrowth Treatment For Men

NDC 70150-005-01

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

NDC Product Information

Rootly Extra Strength Hair Regrowth Treatment For Men with NDC 70150-005 is a a human over the counter drug product labeled by Ttem, Llc. The generic name of Rootly Extra Strength Hair Regrowth Treatment For Men is minoxidil 5%. The product's dosage form is solution and is administered via topical form.

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.

Rootly Extra Strength Hair Regrowth Treatment For Men 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.


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: 08-24-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Rootly Extra Strength Hair Regrowth Treatment For Men Product Label Images

Rootly Extra Strength Hair Regrowth Treatment For Men 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

To regrow hair on the top of the scalp

Warnings

For external use only. Flammable: Keep away from fire or flame.

Otc - Do Not Use

  • Do not use ifYou are a womanYour degree of hair loss is different than that shown on this carton, because this product may not work for youYou have no family history of hair lossYour hair loss is sudden and/or patchyYour hair loss is associated with childbirthYou do not know the reason for your hair lossYou are under 18 years of age. Do not use on babies or children.Your scalp is red, inflammed, infected, irritated, or painfulYou use other medicines on your scalp

Otc - Ask Doctor

Ask a doctor before use if you have heart disease

Otc - When Using

  • When using this productDo not apply on other parts of the bodyAvoid contact with eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water.Some people have experienced change in hair color and/or texture. It takes time to regrow hair. For some men, 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 men.

Otc - Stop Use

  • Stop use and ask doctor ifchest pain, rapid heartbeat, faintness, or dizziness occurssudden, unexplained weight gain occursyour hands or feet swellscalp irritation or redness occursunwanted facial hair growth occursyou 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

If swallowed, get medical help or contact a Poison Control Center right away.

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

Other Information

• see hair loss pictures on side of this carton• before use, read all information on carton and enclosed leaflet• keep the carton. It contains important information.• hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men• in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution• store at controlled room temperature 68º to 77ºF (20º to 25ºC).

Inactive Ingredient

Lcohol, Propylene Glycol, Purified Water

Otc - Questions

Questions or commentsCall toll-free 1-800-681-0241 or visit hellorootly.com

* Please review the disclaimer below.