NDC 57483-542 Regoxidine

Minoxidil

NDC Product Code 57483-542

NDC 57483-542-03

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

NDC Product Information

Regoxidine with NDC 57483-542 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 2 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.

  • 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: ANDA078176 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: 04-19-2021 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 2% w/v

Purpose

Hair regrowth treatment

Use

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

Warnings

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

Do Not Use If

  • Your degree of hair loss is different than that shown on the side of this carton, because this product may not work for youyou have no family history of hair lossyour hair loss is sudden and/or patchyyour hairloss is associated with childbirthyou 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 women, 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 women.

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.

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

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.in clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women reported moderate hair regrowth after using 2% minoxidil topical solution for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth, 33% had minimal regrowth).store at controlled room temperature 20° to 25°C (68° to 77°F).

Inactive Ingredients

Alcohol, propylene glycol, purified water

Consumer Information

  • WOMEN’S REGOXIDINE2% Minoxidil Topical Solution, USPHAIR REGROWTH TREATMENT UnscentedSave this leaflet for future reference.Hair regrowth treatmentPreviously available only by prescriptionOver 30 million American women experience hair thinning or hair loss, so you’re not alone. REGOXIDINE contains the only ingredient that is medically proven effective to help regrow hair in women.Please read this leaflet carefully. It will help you understand how to use REGOXIDINE and what to expect from its use. If you have any questions after reading this leaflet, or anytime while using REGOXIDINE, you should ask your health care professional or call us at +1 800-966-5122, you can also visit our website at www.innovuspharma.com.What is WOMEN’S REGOXIDINE?REGOXIDINE is a colorless liquid medication for use only on the top of the scalp to help regrow hair.Who may use WOMEN’S REGOXIDINE?REGOXIDINE may be appropriate for you if you are an adult who is at least 18 years old and experiencing gradually thinning hair or gradual hair loss on the top of the head. The common hereditary thinning or hair loss process begins slowly and may become noticeable only after years of gradual loss. REGOXIDINE is for general thinning of hair on the top of the scalp as shown in the illustration below. REGOXIDINE has been shown to regrow hair in women with the degrees of hair loss shown. If women have more hair loss than shown, REGOXIDINE may not work. Many of those experiencing hair loss have other family members with gradual thinning hair or hair loss. If there is no family history of gradual thinning or gradual hair loss, or hair loss is patchy, talk to your doctor.Who should NOT use WOMEN’S REGOXIDINE?REGOXIDINE will not prevent or improve hair loss related to pregnancy, the use of some prescription and non-prescription medications, certain severe nutritional problems (very low body iron; excessive vitamin A intake), the recently discontinued use of birth control pills, low thyroid states (hypothyroidism), chemotherapy, or diseases which cause scarring of the scalp. Also, REGOXIDINE 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 REGOXIDINE if hair loss is patchy as shown below.You should ask your doctor if you are unsure of the cause of your hair loss.Will WOMEN’S REGOXIDINE work for me?The amount of hair regrowth is different for each person. Not everyone will respond to REGOXIDINE. The response to REGOXIDINE cannot be predicted. No one will be able to grow back all their hair. In clinical studies of mostly white women aged 18-45 years with mild to moderate degrees of hair loss, the following response to Minoxidil topical solution 2% was reported:19% of women reported moderate hair regrowth after using Minoxidil topical solution 2% for 8 months (19% had moderate regrowth. 40% had minimal regrowth). This compared with 7% of women reporting moderate hair regrowth after using placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth. 33% had minimal regrowth).What Minimal, Moderate and Dense Hair Regrowth Will Mean For You?Can WOMEN’S REGOXIDINE be used to prevent hair loss?We do not know if REGOXIDINE will prevent hair loss.How soon can I expect results from using WOMEN’S REGOXIDINE?Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with REGOXIDINE also takes time. Generally new hair growth is slow for a REGOXIDINE user. Continued use of 2 times a day for at least 4 months is usually needed before you notice hair regrowth. If you do not see hair regrowth in 4 months, stop using REGOXIDINE and see your doctor. When you first begin to use REGOXIDINE, your hair loss may continue for up to 2 weeks. This hair loss is temporary. If you continue to lose hair after two weeks, see your doctor.If WOMEN’S REGOXIDINE is working, what will the hair look like?At first, hair growth may be soft, downy, colorless hairs. 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 WOMEN’S REGOXIDINE?If you respond to REGOXIDINE, you will need to use it 2 times a day to keep and continue the hair regrowth. Up to 8 months of usage may be needed to see your best results from REGOXIDINE.What happens if I completely stop using WOMEN’S REGOXIDINE? Will I keep the new hair?Continuous use of REGOXIDINE is needed to maintain hair regrowth. If you stop using REGOXIDINE, the normal hair loss process will start again. You will probably lose your newly regrown hair in three to four months.What is the dosage of WOMEN’S REGOXIDINE?You should apply a dose (1 mL) of REGOXIDINE directly onto the scalp in the hair loss area TWO TIMES A DAY; for example, once in the morning and once at night. Each bottle should last about one month, if used as directed. Please refer to the "Directions for Use" section of this leaflet.What if I miss a dose or forget to use WOMEN’S REGOXIDINE?If you miss one or two daily doses of REGOXIDINE, just continue with your next dose. You should not make up for missed doses.Can I use WOMEN’S REGOXIDINE more than two times a day? Will it work faster, better?No. REGOXIDINE 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 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 chances of side effects.What are the most common side effects with WOMEN’S REGOXIDINE?The most common side effects are itching and other skin irritations of the treated area of the scalp. REGOXIDINE contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas. If REGOXIDINE accidentally gets into these areas, rinse with large amounts of cool tap water. Contact your doctor if irritation persists.What kind of shampoo should I use with WOMEN’S REGOXIDINE?If you wash your scalp before applying REGOXIDINE, use a mild shampoo.Can I use hair sprays, mousses, conditioners, gels, etc.?Yes. There is no need to change your usual hair care routine when using REGOXIDINE. However, you should apply REGOXIDINE first and wait for it to dry before applying your styling aids.Can I have my hair colored or permed or use hair relaxers while using WOMEN’S REGOXIDINE?Yes. We have no information that these treatments change the effect of REGOXIDINE. However, to avoid possible scalp irritation, you should make sure all of the REGOXIDINE has been washed off the hair and scalp before using these chemicals.Can I apply WOMEN’S REGOXIDINE and wash my hair an hour later?No. For REGOXIDINE to work best, you should allow REGOXIDINE to remain on the scalp for about 4 hours before washing.Can I go swimming or out in the rain?Yes. Avoid washing off the REGOXIDINE. If possible, apply REGOXIDINE to a dry scalp after swimming, or wait about 4 hours after application before going swimming. Do not let your scalp get wet from the rain after applying REGOXIDINE.Can WOMEN’S REGOXIDINE produce unwanted hair?Although unwanted hair growth has been reported on the face and on other parts of the body, such reports have been infrequent. The unwanted hair growth may be caused by the transfer of REGOXIDINE to areas other than the scalp, or by absorption into the circulatory system of low levels of the active ingredient, or by a medical condition not related to the use of REGOXIDINE.If you experience unwanted hair, discontinue using REGOXIDINE and see your doctor for recommendations about appropriate treatment. After stopping use of REGOXIDINE, the unwanted hair, if caused by the use of REGOXIDINE, should go away over time.You can take steps to decrease the chances for unwanted hair growth:1. limit the application of REGOXIDINE only to the scalp,2. if you use your hands to apply REGOXIDINE, wash your hands thoroughly afterwards, and3. allow sufficient drying time (usually 2 to 4 hours before going to bed) after your nighttime application of REGOXIDINE.Can I use WOMEN’S REGOXIDINE for baldness or hair loss in babies and children?No. REGOXIDINE must not be used to treat baldness or hair loss in babies or children.Are there any special warnings about the use of WOMEN’S REGOXIDINE?For external use onlyFlammable: Keep away from fire or flameDo not use ifyour degree of hair loss is more than that shown on the illustration on page 1 of this leaflet, because this product may not work for you • you have no family history of hair loss • your hair loss is sudden and/or patchy • your hair loss is associated with childbirth • 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 scalpAsk a doctor before use if you have heart disease.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. • some people have experienced changes in hair color and/or texture • it takes time to regrow hair. 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 everyone.Stop use and ask a doctor if • chest pain, rapid heartbeat, faintness, or dizziness occurs • scalp irritation or redness occurs • sudden, unexplained weight gain occurs • unwanted facial hair growth occurs • your hands or feet swell • you 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 other factors may increase the risk of serious side effects with WOMEN’S REGOXIDINE?REGOXIDINE should be applied only to the scalp. The risk of side effects may be greater when it is applied to other parts of the body.Directions for Use1. Remove the cap. To remove, push down and turn in direction of the arrows on the cap.2. Part your hair in the area of hair thinning/loss.Follow the instructions below for using the dropper applicator and 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.Using the Dropper ApplicatorSqueeze the rubber bulb and insert the dropper into the bottle. Release the bulb, allowing the dropper to fill to the 1 mL line. If the level of the solution is above the 1 mL line, squeeze the extra amount back into the bottle.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.After each use attach the dropper to the bottle to make it child-resistant by turning it clockwise until tightly closed.If you have any other questions, ask your health care professional or call us at +1 800-996-5122. You can also visit our website at www.innovuspharma.comStore at USP Controlled Room Temperature 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 # REG2002-INSLabel rev. date 02/21

* Please review the disclaimer below.