NDC 0113-7202 Basic Care Hair Regrowth Treatment

Minoxidil

NDC Product Code 0113-7202

NDC Code: 0113-7202

Proprietary Name: Basic Care Hair Regrowth Treatment Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.


Code Structure
  • 0113 - L. Perrigo Company
    • 0113-7202 - Basic Care Hair Regrowth Treatment

NDC 0113-7202-30

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

NDC Product Information

Basic Care Hair Regrowth Treatment with NDC 0113-7202 is a a human over the counter drug product labeled by L. Perrigo Company. The generic name of Basic Care Hair Regrowth Treatment is minoxidil. The product's dosage form is solution and is administered via topical form.

Labeler Name: L. Perrigo Company

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 Additional informationCallout TooltipWhat 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.


Basic Care Hair Regrowth Treatment Active Ingredient(s)

Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: L. Perrigo Company
Labeler Code: 0113
FDA Application Number: ANDA075357 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-06-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Basic Care Hair Regrowth Treatment Product Label Images

Basic Care 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

Active Ingredient

Minoxidil 2% w/v

Purpose

Hair regrowth treatment

Use

To regrow hair on the scalp

Warnings

For external use onlyFlammable: 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 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 scalp

Ask 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 •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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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. •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 compares with 7% of women reporting moderate hair regrowth after using the placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth). •store at 20° to 25°C (68° to 77°F). Keep tightly closed.

Inactive Ingredients

Alcohol, propylene glycol, purified water

Consumer Information

  • IMPORTANT INFORMATION ABOUTMinoxidil Topical Solution USP 2%Hair Regrowth TreatmentUNSCENTEDFor WomenOver 30 million American women experience hair thinning or hair loss, so you're not alone. Minoxidil topical solution 2% contains the only ingredient that is medically proven effective to help regrow hair in women. •Clinically Proven to Help Regrow Hair •Reactivates Hair Follicles To Stimulate Regrowth •Previously Available Only by PrescriptionSAVE THIS LEAFLET FOR FUTURE REFERENCEPlease read this leaflet carefully. It will help you understand how to use minoxidil topical solution 2% and what to expect from its use. If you have any questions after reading this leaflet, or anytime while using minoxidil topical solution 2%, you should ask your health care professional or call us at 1-800-719-9260.What is minoxidil topical solution 2%?Minoxidil topical solution 2% is a colorless liquid medication for use only on the top of the scalp to help regrow hair.Who may use minoxidil topical solution 2%?Minoxidil topical solution 2% 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.Minoxidil topical solution 2% is for general thinning of hair on the top of the scalp as shown below. Minoxidil topical solution 2% has been shown to regrow hair in women with the degrees of hair loss shown. If women have more hair loss than shown, minoxidil topical solution 2% 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 minoxidil topical solution 2%?Minoxidil topical solution 2% 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, minoxidil topical solution 2% 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 minoxidil topical solution 2% 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 minoxidil topical solution 2% work for me?The amount of hair regrowth is different for each person. Not everyone will respond to minoxidil topical solution 2%. The response to minoxidil topical solution 2% cannot be predicted. No one will be able to grow back all their hair.In clinical studies of mostly white woman aged 18-45 years with mild to moderate degrees of hair loss, the following response to minoxidil topical solution 2% was reported:FEMALE RESPONSE TO MINOXIDIL TOPICAL SOLUTION 2%Percent reporting hair growth19% of women reported moderate hair regrowth after using minoxidil topical solution 2% for 8 months (19% had moderate regrowth; 40% had minimal regrowth). This compares with 7% of women reporting moderate hair regrowth after using the 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 YouNumber of HairsHair Density MinimalSome new hairs are seen, but not enough to cover thinning areas.Hairs in thinning areas do not grow as closely together as hairs on the rest of the head. ModerateNew hairs cover some or all of thinning areas.Hairs in the thinning areas grow more closely together, but are not as close together as hairs on the rest of the head. DenseNew hairs cover, or almost completely cover, thinning areas.Hairs in thinning areas grow as closely together as hairs on the rest of head.Can minoxidil topical solution 2% be used to prevent hair loss?We do not know if minoxidil topical solution 2% will prevent hair loss.How soon can I expect results from using minoxidil topical solution 2%?Since normal hair usually grows only 1/2 to 1 inch per month, hair regrowth with minoxidil topical solution 2% also takes time. Generally new hair growth is slow for a minoxidil topical solution 2% 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 minoxidil topical solution 2% and see your doctor.When you first begin to use minoxidil topical solution 2%, 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 minoxidil topical solution 2% 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 minoxidil topical solution 2%?If you respond to minoxidil topical solution 2%, 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 minoxidil topical solution 2%.What happens if I completely stop using minoxidil topical solution 2%? Will I keep the new hair?Continuous use of minoxidil topical solution 2% is needed to maintain hair regrowth. If you stop using minoxidil topical solution 2%, 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 minoxidil topical solution 2%?You should apply a dose (1 mL) of minoxidil topical solution 2% 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 minoxidil topical solution 2%?If you miss one or two daily doses of minoxidil topical solution 2%, just continue with your next dose. You should not make up for missed doses.Can I use minoxidil topical solution 2% more than two times a day? Will it work faster, better?No. Minoxidil topical solution 2% 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 minoxidil topical solution 2% 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 minoxidil topical solution 2%?The most common side effects are itching and other skin irritations of the treated area of the scalp. Minoxidil topical solution 2% contains alcohol, which would cause burning or irritation of the eyes or sensitive skin areas. If minoxidil topical solution 2% 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 minoxidil topical solution 2%?If you wash your scalp before applying minoxidil topical solution 2%, 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 minoxidil topical solution 2%. However, you should apply minoxidil topical solution 2% 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 minoxidil topical solution 2%?Yes. We have no information that these treatments change the effect of minoxidil topical solution 2%. However, to avoid possible scalp irritation, you should make sure all of the minoxidil topical solution 2% has been washed off the hair and scalp before using these chemicals.Can I apply minoxidil topical solution 2% and wash my hair an hour later?No. For minoxidil topical solution 2% to work best, you should allow minoxidil topical solution 2% 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 minoxidil topical solution 2%. If possible, apply minoxidil topical solution 2% 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 minoxidil topical solution 2%.Can minoxidil topical solution 2% 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 minoxidil topical solution 2% 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 minoxidil topical solution 2%.If you experience unwanted hair, discontinue using minoxidil topical solution 2% and see your doctor for recommendations about appropriate treatment. After stopping use of minoxidil topical solution 2%, the unwanted hair, if caused by the use of minoxidil topical solution 2%, should go away over time.You can take steps to decrease the chances for unwanted hair growth:1) limit the application of minoxidil topical solution 2% only to the scalp, 2) if you use your hands to apply minoxidil topical solution 2%, wash your hands thoroughly afterwards, and 3) allow sufficient drying time (usually 2 to 4 hours before going to bed) after your nighttime application of minoxidil topical solution 2%.Can I use minoxidil topical solution 2% for baldness or hair loss in babies and children?No. Minoxidil topical solution 2% must not be used to treat baldness or hair loss in babies or children.Are there any special warnings about the use of minoxidil topical solution 2%?For external use onlyFlammable: Keep away from fire or flameDo not use if •your degree of hair loss is more than that shown on the other side 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. (1-800-222-1222)What factors may increase the risk of serious side effects with minoxidil topical solution 2%?Minoxidil topical solution 2% 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 minoxidil topical solution 2%.Using the Dropper Applicator1) Squeeze 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.2) 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.3) 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 1-800-719-9260.Store at 20º to 25ºC (68º to 77ºF).Keep tightly closed.Save this leaflet for future reference.Made in IsraelManufactured By PerrigoYeruham 80500, IsraelRev 03-14: 20200 00 J3

* Please review the disclaimer below.

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