NDC 54111-205 Hair Regrow

NDC Product Code 54111-205

NDC 54111-205-60

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 60 mL in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Hair Regrow with NDC 54111-205 is a product labeled by Bentley Laboratories, Llc. The generic name of Hair Regrow is . The product's dosage form is and is administered via form.

Labeler Name: Bentley Laboratories, Llc

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.

  • ALCOHOL (UNII: 3K9958V90M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)

Product Labeler Information

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

Labeler Name: Bentley Laboratories, Llc
Labeler Code: 54111
Start Marketing Date: 08-24-2004 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: 12-31-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

Information for Patients

Minoxidil Oral

Minoxidil Oral is pronounced as (mi nox' i dill)

Why is minoxidil oral medication prescribed?
Minoxidil is used with other medications to treat high blood pressure. It is in a class of medications called vasodilators. It works by relaxing the blood vessels so that...
[Read More]
Minoxidil Topical

Minoxidil Topical is pronounced as (mi nox' i dill)
Why is minoxidil topical medication prescribed?
Minoxidil is used to stimulate hair growth and to slow balding. It is most effective for people under 40 years of age whose hair loss is recent. Minoxidil has no effect o...
[Read More]

* Please review the disclaimer below.

Hair Regrow Product Label Images

Hair Regrow 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

Active Ingredient

Minoxidil 5% w/v

Purpose

Hair regrowth treatment for men

Use

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

Warnings

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

Do Not Use If

  • You are a womanyour amount of hair loss is different than that shown on the side of this carton, or your hair loss is on the front of the scalp.  5% minoxidil topical solution is not intended for frontal baldness or receding hairline.you have no family history of hair lossyour hair loss is sudden and/or patchyyou do not know the reason for your hair lossyou are under 18 years of age.  Do not use on babies and children.your scalp is red, inflammed, infected, irritated, or painfulyou use other medicines on the scalp

When Using This Product

  • Do not apply on other part of the bodyavoid contact with the eyes.  In case of accidental contact, rinse eyes with large amounts of cool tap water.some individuals (people) have experienced changes in hair color and/or textureit takes time to regrow hair.  Results may occur at 2 months with 2 times daily usage of this product.  For some men, you may need to use this product 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.

Stop Use And Ask A Doctor If

  • Chest pain, rapid heartbeat, faintness, or dizziness occurssudden, unexplained weight gain occursyour hands or feet swellscalp irritation or redness occursyou get unwanted facial hair growthyou 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

  • 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 resultscontinued 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 cartonbefore use, read all information on carton and enclosed booklet.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 solutions for men.In clinical studies with mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth that 2% minoxidil topical solution.store at controlled room temperature 20° to 25° C (68° to 77° F)

Inactive Ingredients

Alcohol, Propylene Glycol, Purified Water

Questions?

  • 1-866-270-HAIR (4247)9 am to 2 pm weekdays ESTVisit www.MyHairRegrow.com

Men's Extra Strength Hair Regrow

Help regrow your hair with confidence5% Minoxidil Topical SolutionHair Regrowth TreatmentUnscentedExtra Strength FormulaReactivates hair follicles to stimulate regrowthMinoxidil is clinically proven to help regrow hairCompare to Men's Rogaine​® Active Ingredient*Not for use by women30 day supply / 1-60 mL (2 fl oz) bottle

* Please review the disclaimer below.