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| Product NDC Code | 72764-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Grow girl |
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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 | SOLUTION | ||||
| RxCUI drug identifier | 311723 | ||||
| Application Number | ANDA078176 | ||||
| Labeler Name | Brandable, Inc. | ||||
| 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.Minoxidil 2% w/w
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 Apply one mL with dropper 2 times a day directly onto the scalp in the hair loss area Using more or more ofthen will not improve results Continued use is necessary to increase and keep your hair regrowth, 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 Use to regrow hair on the scalp
Purpose
Information about the drug product’s indications for use.Hair regrowth treatment
Spl product data elements
Usually a list of ingredients in a drug product.GROW GIRL MINOXIDIL PROPYLENE GLYCOL MINOXIDIL MINOXIDIL WATER ISOPROPYL ALCOHOL
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.Label 1 Label 2
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 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 or children Your scalp is red, inflamed, infected, irritated, or painful You use other medicines on the scalp
GROW GIRL: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.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 expereinced changes in hair color and/or texture 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 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 everyone.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information See hair loss pictures on the side of this carton Before use, read all information on carton and enclosed leaflet Keep the carton. It contains important information In clincial studies of mostly white women aged 18-45 years with moderate degrees of hair loss, the following responses 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 hair regrowth). This compares with the 7% of women reporting moderate hair regrowth after using a placebo, the liquid without minoxidil in it, for 8 months (7% had moderate regrowth; 33% had minimal regrowth). Store at controlled room temperature 20 o to 25 o C (68 o to 77 o F)
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? Toll-free (877) 281-3001 Visit our website at www.GrowGirlHair.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 heart beat, faintness, or dissiness occurs Sudden, unexplained weight gain occurs Your hands of feet swell Scalp irritation or redness occurs You get unwanted facial hair growth You do not see hair regrowth in 4 months
Pregnancy or breast feeding
Pregnancy or Breast feedingMay be harmful if used when pregnant or breast-feeding.
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.For external use only. Flamable: Keep away from fire of flame.
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