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| Product NDC Code | 72484-097 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Minoxidil extra strength for men |
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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 | 1537948 | ||||||
| Application Number | ANDA076239 | ||||||
| Labeler Name | Roman Health Ventures 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.1 Bottle Carton Active Ingredient Minoxidil, USP 5% w/v 3 Bottle Carton Active Ingredient Minoxidil 5% w/v
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 the bottle upright and pump the sprayer 5 times to ensure delivery of full spray. Do not inhale mist Apply one mL with spray (6 sprays) 2 times a day directly onto the scalp in the hair loss area Using more or more often will not improve restuls Continued use is necessary to increase and keep your hair regrowth, or hair loss will begind 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.1 Bottle Carton Use to regrow hair on the scalp (vertex only, see picture on side of carton) 3 Bottle Carton Use to regrow hair on the scalp (vertex only, see picture on side of carton)
Purpose
Information about the drug product’s indications for use.1 Bottle Carton Purpose Hair regrowth treatment for men 3 Bottle Carton Purpose Hair regrowth treatment
Spl product data elements
Usually a list of ingredients in a drug product.Minoxidil Extra Strength for Men Minoxidil MINOXIDIL MINOXIDIL ALCOHOL WATER PROPYLENE GLYCOL
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.Three Bottle Package NDC xxxxx-xxx-xx roman HAIR REGROWTH TREATMENT 5% Minoxidil Topical Solution, USP Extra Strength formula for men Clinically proven to help regrow hair Reactivates hair follicles to stimulate growth Easy precision sprayer Unscented topical solution Three month supply 3- 60 mL (2 fl oz) bottles Total 180 mL (6 fl oz) Not for use by women 3 Bottle
Single Bottle Package NDC XXXXX-XXX-XX roman Hair Regrowth Treatment 5% Minoxidil Topical Solution, USP Extra Strength formula for men Clinically proven to help regrow hair Reactivates hair follicales to stimulate regrowth Easy precision sprayer Unscented topical solution One month supply 1 - 60 mL (2 fl oz) bottle Not for use by women. 1 bottle
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
Distributed by Roman Health Ventures, Inc. 116 W. 23rd Street, 4th Floor New York, NY 10011 www.ro.co
NOT FOR USE BY WOMEN: May grow facial hair. May be harmful if used during pregnancy or breast-feeding Minoxidil 5% Topical Solution, USP Minoxidil 5% Topical Solution is for men who have a general thinning of hair on the top of the scalp vertex only, as shown below. Not intended for frontabl baldness or a receding hairline. Minoxidil Topical Solution 5% has been shown to regrow hair in men with the following degrees of thinning hair or hairloss. If men have more hair loss or hair loss in a place different than showing above, Minoxidil Topical Solution 5% for men may not work. For best results: Apply direclty to scalp. Use twice daily.
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 side of this carton Before use, read all information on carton and enclosed leaflet Hair regrowth has not been shown to last longer than 48 weeks in large clinical trials with continuous treatment with 5% minoxidil topical solution for men Keep the carton. It contains important information. In clinical studies of mostly white men aged 18-45 years with moderate degrees of hairloss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution Store at controlled room temperature 20 to 25C (68 to 77F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-424-347-6299 Visit website at ro.co
| Questions? 1-424-347-6299 Visit website at ro.co |
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. For use by men only. Flammable: Keep away from fire or 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