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| Product NDC Code | 70550-578 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Keranique hair regrowth treatment for women |
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| Type | Brand | ||||||||||
| Pharm Class | Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | SPRAY | ||||||||||
| RxCUI drug identifier | 1537947 | ||||||||||
| Application Number | ANDA078176 | ||||||||||
| Labeler Name | PROFECTUS BEAUTY, LLC | ||||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Minoxidil 2% w/v Purpose Hair regrowth treatment
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions prime the sprayer by holding the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist. apply 1mL with sprayer (6 sprays) 2 times a day directly onto the scalp in the hair loss area using more often will not improve results continued use is necessary or hair loss will begin again
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Alcohol, Propylene Glycol, Purified Water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use to regrow hair on the scalp
Purpose
Information about the drug product’s indications for use.Purpose Hair regrowth treatment
Spl product data elements
Usually a list of ingredients in a drug product.KERANIQUE Hair Regrowth Treatment For Women MINOXIDIL ALCOHOL PROPYLENE GLYCOL WATER MINOXIDIL MINOXIDIL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Package Labelling:70550-578-01 Label1.jpg
Package Labelling:70550-578-02 Label2.jpg
Package Labelling:70550-578-03 Label3.jpg
Package Labelling:70550-578-04 Label4.jpg
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other Information see hair loss pictures on side of this carton before use, read all information on carton and enclosed booklet keep the carton. It contains important information. In clinical studies of mostly white women aged 18-45 years with mild to moderate diagnosis of hair loss, the following response to 2% minoxidil topical solution was reported: 19% of women imported 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 incidental 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 Controlled Room Temperature 20 to 25 C (68° to 77° F)
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor before use if you have heart disease
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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 your 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 year 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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? Call toll free 1-888-237-4131 Visit website: www.keranique.com
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not apply on other parts of the body avoid eye 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.
Pregnancy or breast feeding
Pregnancy or Breast feedingMay be harmful if used when pregnant or breastfeeding.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 you your 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 year 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 eye 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 May be harmful if used when pregnant or breastfeeding. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API