NDC 69188-001 Mens Spectral Uhp Extra Strength Hair Regrowth Treatment

Minoxidil 5%

  1. Labeler Index
  2. Ds Healthcare Group, Inc.
  3. NDC: 69188-001 Mens Spectral Uhp Extra Strength Hair Regrowth Treatment

NDC Product Code 69188-001

NDC CODE: 69188-001

Proprietary Name: Mens Spectral Uhp Extra Strength Hair Regrowth Treatment 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • Minoxidil is used with other medications to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Minoxidil works by relaxing blood vessels so blood can flow more easily.

NDC Code Structure

  • 69188 - Ds Healthcare Group, Inc.

NDC 69188-001-01

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

NDC 69188-001-02

Package Description: 3 BOTTLE in 1 BOX > 60 mL in 1 BOTTLE

NDC Product Information

Mens Spectral Uhp Extra Strength Hair Regrowth Treatment with NDC 69188-001 is a a human over the counter drug product labeled by Ds Healthcare Group, Inc.. The generic name of Mens Spectral Uhp Extra Strength Hair Regrowth Treatment is minoxidil 5%. The product's dosage form is solution and is administered via topical form.

Labeler Name: Ds Healthcare Group, Inc.

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.

Mens Spectral Uhp Extra Strength Hair Regrowth Treatment 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.
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • 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: Ds Healthcare Group, Inc.
Labeler Code: 69188
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: 12-19-2020 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: 12-31-2021 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.

Information for Patients

Minoxidil

Minoxidil is pronounced as (mi nox' i dill)

Why is minoxidil 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.

Mens Spectral Uhp Extra Strength Hair Regrowth Treatment Product Label Images

Mens Spectral Uhp Extra Strength Hair Regrowth Treatment 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 (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

Otc - Do Not Use

Do not use if■ You are a woman■ Your amount of hair loss is dierent than that shown on the side of this carton, or your hair loss is on the front of the scalp.Minoxidil topical solution 5% is not intended for frontal baldness or receding hairline.■ You have no family history of hair loss■ Your 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 on babies and 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 eyes with large amounts of cool tap water.■ It takes time to regrow hair. Results may occur at 2 months with twice 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. This product will not work for all men.■ Some people have experienced changes in hair color and/or texture

Otc - Stop Use

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

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

  • Prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure deliveryof full spray. Do not inhale mist.apply 1 mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss areausing 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 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 withcontinuous treatment with 5% minoxidil topical solution for men • in clinical studies of mostlywhite men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solutionfor men provided more hair regrowth than 2% minoxidil topical solution• store at controlled room temperature 20º to 25ºC (68º to 77ºF)

Inactive Ingredient

Alcohol, propylene glycol, purified water

Otc - Questions

Questions or comments? call toll free (888) 829-4212 or visit website at www.dslaboratories.com

* Please review the disclaimer below.