NDC 57483-535 Regoxidine

Minoxidil

NDC Product Code 57483-535

NDC 57483-535-03

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

NDC Product Information

Regoxidine with NDC 57483-535 is a a human over the counter drug product labeled by Innovus Pharmaceuticals Inc.. The generic name of Regoxidine is minoxidil. The product's dosage form is solution and is administered via topical form.

Labeler Name: Innovus Pharmaceuticals 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.

Regoxidine 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 3 g/60mL

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)

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: Innovus Pharmaceuticals Inc.
Labeler Code: 57483
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: 05-20-2021 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.

Regoxidine 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, inflamed, infected, irritated, or painfulyou use other medicines on the scalp

Ask A Doctor Before Ue If You Have

Heart disease

When Using This Product

  • Do not apply on other parts of the bodyavoid 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 textureit 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 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 occursunwanted facial hair growth occursyou do not see hair regrowth in 4 months

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 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 cartonbefore use, read all information on carton and enclosed leafletkeep 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 minoxidil topical solution 5% for menin 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 than 2% minoxidil topical solutionstore at controlled room temperature 20° to 25°C (68° to 77°F).

Inactive Ingredients

Alcohol, propylene glycol, purified water,

Consumer Informaition

  • MEN'S REGOXIDINE EXTRA STRENGTH5% Minoxidil Topical Solution, USPHAIR REGROWTH TREATMENTUnscentedSave this leaflet for future referenceIt 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 product for at least 4 months before you see results. Please read this leaflet carefully. It will help you understand how to use Regoxidine Extra Strength and what to expect from its use. If you have any questions after reading this leaflet, or anytime while using Regoxidine Extra Strength, you should ask your healthcare professional or call us at +1-800-996-5122. you can also contact us at our website at www.innovuspharma.comWhat is Mens'Regoxidine Extra Strength?Regoxidine Extra Strength is a colorless liquid medication containing 5% minoxidil for use only on the scalp to help regrow hair in men.Who may use Regoxidine Extra Strength?Regoxidine Extra Strength is for use only by men. Regoxidine Extra Strength may be appropriate for you if you are a male at least 18 years old and experiencing gradually thinning hair or gradual hair loss on the top of the scalp (vertex only, as shown on the illustration that follows). It is not intended for frontal baldness or a receding hairline. The common inherited thinning or hair loss process begins slowly and may become noticeable only after years of gradual loss.Regoxidine Extra Strength is for men with hair loss or thinning hair that begins on the vertex of the scalp. Regoxidine Extra Strength is more likely to regrow hair in men with hair loss in the range shown below. If men have more hair loss than shown, Regoxidine Extra Strength may not work.Many of those experiencing hair loss have other family members with gradual thinning hair or hair loss. If you have no family history of gradual thinning hair or of gradual hair loss, or your hair loss is patchy, see your doctor.Who should not use Regoxidine Extra Strength?Women should not use Regoxidine Extra Strength because studies have shown it works no better in women than Women's 2% Minoxidil Topical Solution. Some women may also grow facial hair. In addition, Regoxidine Extra Strength may be harmful if used during pregnancy or breast-feeding.Regoxidine Extra Strength should not be used on babies or for children under 18 years old.Regoxidine Extra Strength will not prevent or improve hair loss which may occur with the use of some prescription and non-prescription medications, certain severe nutritional problems (very low body iron; too much vitamin A intake), low thyroid states (hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp.Also, Regoxidine Extra Strength will not improve hair loss due to:damage from the use of hair care products which cause scarring or deep burns of the scalp.hair grooming methods such as cornrowing or ponytails which require pulling the hair tightly back from the scalp.Do not use if you are not sure of the reason for your hair loss.Will Regoxidine Extra Strength work for me?The amount of hair regrowth is different for each person. Not everyone will respond to Regoxidine Extra Strength. The response to Regoxidine Extra Strength cannot be predicted. It is unlikely anyone will be able to grow back all their hair. However, to see your best results with Regoxidine Extra Strength, make sure you get the medicine directly to the scalp and apply it twice a day, every day. You may get better results if you have been losing your hair for a short period of time or have little hair loss. However, for some men Regoxidine Extra Strength may not work.How soon can I expect results from using Regoxidine Extra Strength?Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with Regoxidine Extra Strength also takes time. Results may be seen as early as 2 months with twice daily use.For some men, it may take at least 4 months for results to be seen. If you do not see any results after 4 months, stop using Regoxidine Extra Strength. When you first begin to use Regoxidine Extra Strength, your hair loss may increase temporarily for up to 2 weeks. This is likely a sign that you are getting rid of old hairs in order to regrow more new hairs. This temporary increase in hair loss is expected and is a part of the process for how Regoxidine Extra Strength regrows hair. Remember, this increased hair loss is temporary. However, if it continues after two weeks, see your doctor.What Minimal, Moderate and Dense Hair Regrowth Will Mean for You?If Regoxidine Extra Strength is working, what will the hair look like?At first, hair growth is usually soft, downy, colorless hairs (like peach fuzz). After further use, the new hairs should be the same color and thickness as the other hairs on your scalp.How long do I need to use Regoxidine Extra Strength?If you experience hair regrowth, continued use of Regoxidine Extra Strength is necessary or the hair loss will begin again. In studies with 5% minoxidil topical solution, hair regrowth has not been shown to last longer than 48 weeks of continuous treatment in large clinical trials.What happens if I completely stop using Regoxidine Extra Strength? Will I keep the new hair?Continuous use of Regoxidine Extra Strength is needed to maintain hair regrowth. If you stop using Regoxidine Extra Strength, you will lose your newly regrown hair in 3 to 4 months.How do I use Regoxidine Extra Strength?For best results, apply 1 mL with applicator 2 times a day directly onto the scalp in the hair loss area. Using more or using more often will not improve results. Each bottle should last one month, if used as directed.Allow time for Regoxidine Extra Strength to dry completely before wearing a hat, or lying on a pillow, etc. Regoxidine Extra Strength may cause staining of clothing or linens if damp on the scalp. When applying Regoxidine Extra Strength at night, be sure to allow 2 to 4 hours to dry completely. Never take this product by mouth or apply to other parts of the body.When do I use Regoxidine Extra Strength?Apply Regoxidine Extra Strength once in the morning and once at night. The nighttime application should occur 2 to 4 hours before going to bed to allow for drying. Each bottle should last one month, if used as directed.What if I miss a dose or forget to use Regoxidine Extra Strength?If you miss one or two daily doses of Regoxidine Extra Strength, just continue with your next dose. You should not make up for missed doses.Can I use Regoxidine Extra Strength more than twice a day? Will it work faster, better?No. Regoxidine Extra Strength will not work faster or better if used more than two times a day. Studies have been carefully conducted to determine the correct amount of Regoxidine Extra Strength needed to get the best results. More frequent use or larger doses have not been shown to speed up hair growth and may increase your chance of side effects.What kind of shampoo should I use with Regoxidine Extra Strength?If you wash your scalp before applying Regoxidine Extra Strength, use a mild shampoo.Can I use hair sprays, mousses, conditioners, gels, etc.?Yes. Hair sprays, spritz, or styling aids may be used on your hair while using Regoxidine Extra Strength. For best results, Regoxidine Extra Strength should be allowed to soak into the scalp before using any styling products. Try to develop a good routine of applying Regoxidine Extra Strength first, and then applying styling products and style as usual. Keep in mind that your best results will be seen with proper application.Can I have my hair colored or permed or use hair relaxers while using Regoxidine Extra Strength?Yes. We have no evidence that coloring or perming your hair or that the use of relaxers change the effect of Regoxidine Extra Strength. However, because the use of a permanent wave and hair color can cause scalp irritation on certain people, we recommend the following precautions:To avoid possible scalp irritation, you should make sure all of the Regoxidine Extra Strength has been washed off the hair and scalp before using color or perm chemicals.For best results, do not apply Regoxidine Extra Strength on the same day that you use a chemical treatment on your hair.Do not use Regoxidine Extra Strength for 24 hours after using any chemicals to make sure your scalp has not been irritated by the perm or color treatment. If no irritation occurs, continue use of Regoxidine Extra Strength as usual.Simply restart your normal Regoxidine Extra Strength routine. There is no need to use more Regoxidine Extra Strength to make up for missed applications. Missing one day of Regoxidine Extra Strength will not affect your hair regrowth results.Can I apply Regoxidine Extra Strength and wash my hair an hour later?No. For Regoxidine Extra Strength to work best, you should allow it to stay on the scalp for about 4 hours before washing.Directions for UseWhen applying Regoxidine Extra Strength, make sure the medicine comes in direct contact with the scalp. Carefully follow the instructions below to use the child-resistant dropper to apply Men's Regoxidine Extra Strength:Remove the bottle of Men's Regoxidine Extra Strength from the carton.To remove the child resistant cap, push down and turn in direction of the arrows on the cap. Discard cap after use.Remove the dropper from the carton.Squeeze the rubber bulb and insert the dropper into the bottle.Release the bulb, allowing the dropper to fill to the 1 mL line, squeeze the extra amount back into the bottle.Part your hair in the area of hair thinning/loss.Next, place the tip of the dropper near the part of the scalp you want to treat and gently squeeze the bulb to gradually release the solution. To prevent the solution from running off the scalp, apply a small amount at a time.apply one mL 2 times a day directly onto the scalp in the hair loss area. Do not use more. Spread the liquid evenly over the hair loss area. If you use your fingers, wash hands with soap and water immediately.Each bottle should last about one month, if used as directed. Use a mild shampoo if you wash your scalp before applying Regoxidine Extra Strength.After each use attach the dropper to the bottle to make it child-resistant by turning it clockwise until tightly closed.WarningsFor external use onlyFor use by men onlyFlammable: Keep away from fire or flameDo not use ifyou are a womanyour amount of hair loss is different than that shown on the other side of this leaflet or your hair loss is on the front of the scalp. Regoxidine Extra Strength 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.scalp is red, inflamed, infected, irritated, or painfulyou use other medicines on the scalpAsk a doctor before use if you have heart disease.When using this productdo not apply on other parts of the bodyavoid 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 textureit 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 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 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 monthsMay 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.What are the most common side effects with Regoxidine Extra Strength?The most common side effects are itching and skin irritation of the treated area of the scalp. If scalp irritation continues, stop use and see a doctor. Regoxidine Extra Strength contains alcohol, which will cause burning or irritation of the eyes. If Regoxidine Extra Strength accidentally gets into eyes, rinse with large amounts of cool tap water.Can Regoxidine Extra Strength produce unwanted hair growth?Unwanted hair growth on the face and other parts of the body has been reported in women. But it is rare and reversible. If you develop unwanted hair, stop using Regoxidine Extra Strength. Over time, the unwanted hair, if caused by Regoxidine Extra Strength, will go away. You can take the following steps to decrease the chances of unwanted hair growth:limit the application of Regoxidine Extra Strength only to the scalp;if you use your hands to apply Regoxidine Extra Strength, wash your hands well immediately afterwards; andafter your nighttime application of Regoxidine Extra Strength, allow enough drying time before going to bed (usually 2 to 4 hours).Can I use Regoxidine Extra Strength for baldness or hair loss in babies or children?No. Regoxidine Extra Strength must not be used to treat baldness or hair loss in babies and children.If you have any other questions, ask your healthcare professional or call toll free +1-800-996-5122 (collect). You can also visit our website at www.innovuspharma.comStore at Controlled Room Temperature at 20º to 25ºC (68º to 77ºF).Save this leaflet for future reference.Innovus Pharmaceuticals, Inc.373 Inverness Pkwy #206Englewood, CO 80112 U.S.A.Label part # REG2000-INSLabel rev. date 02/21

* Please review the disclaimer below.