Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 51326-165 | ||||
|---|---|---|---|---|---|
| Drug Name | Mens minoxidil hair regrowth |
||||
| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 311724 | ||||
| Application Number | ANDA076239 | ||||
| Labeler Name | Topiderm, Inc | ||||
| Packages |
|
||||
| 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 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 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
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 (vertex only, see picture on side of carton)
Purpose
Information about the drug product’s indications for use.Purpose Hair regrowth treatment for men
Spl product data elements
Usually a list of ingredients in a drug product.Mens Minoxidil Hair Regrowth MINOXIDIL Mens Minoxidil Hair Growth System MINOXIDIL MINOXIDIL MINOXIDIL ALCOHOL PROPYLENE GLYCOL WATER Strengthening Basil Root Shampoos (non-coloring) WATER COCAMIDOPROPYL BETAINE SODIUM LAUROYL SARCOSINATE SODIUM COCOYL ISETHIONATE SODIUM LAURYL SULFOACETATE GLYCERIN PANTHENOL PROPYLENE GLYCOL .ALPHA.-TOCOPHEROL ACETATE DIOSCOREA VILLOSA TUBER TRIFOLIUM PRATENSE FLOWER POTASSIUM SORBATE SPHINGANINE CITRIC ACID MONOHYDRATE ESCULIN GLYCOL DISTEARATE POLIDOCANOL C11-15 ALKETH-7 DIPROPYLENE GLYCOL DECYL GLUCOSIDE POLYQUATERNIUM-10 (400 MPA.S AT 2%) POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) PEG-55 PROPYLENE GLYCOL OLEATE MENTHONE 1,2-GLYCEROL KETAL, (+/-)- TRIDECETH-12 ACETYL TETRAPEPTIDE-3 BUTYLENE GLYCOL BENZYL ALCOHOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE SODIUM BENZOATE SODIUM HYDROXIDE BUTYLATED HYDROXYTOLUENE EDETATE DISODIUM ANHYDROUS PHENOXYETHANOL BASIL LOQUAT PEA AMODIMETHICONE (1300 CST) DEXTRAN 110 Rejuvenating Basil Root Conditioner Shampoos (non-coloring) WATER STEARALKONIUM CHLORIDE CETOSTEARYL ALCOHOL STEARYL ALCOHOL TRIFOLIUM PRATENSE FLOWER POTASSIUM SORBATE SPHINGANINE CITRIC ACID MONOHYDRATE RESVERATROL SILIBININ CAFFEINE ESCULIN POLYOXYL 40 HYDROGENATED CASTOR OIL CYCLOMETHICONE 5 ACETYL TETRAPEPTIDE-3 BUTYLENE GLYCOL ZINC PIDOLATE COPPER PIDOLATE SODIUM CHLORIDE SODIUM BENZOATE EDETATE DISODIUM ANHYDROUS PHENOXYETHANOL BASIL LOQUAT PEA TEA LEAF OIL DEXTRAN 110 LECITHIN, SOYBEAN
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.PRINCIPAL DISPLAY PANEL - Kit Carton MINOXIDIL HAIR REGROWTH SYSTEM CLINICALLY PROVEN TO HELP REGROW HAIR KIT CONTENTS: STRENGTHENING SHAMPOO, REJUVENATING CONDITIONER, MINOXIDIL TOPICAL SOLUTION USP (2 MONTH SUPPLY) PRINCIPAL DISPLAY PANEL - Kit Carton
PRINCIPAL DISPLAY PANEL - 2-60 ml Bottle Dropcard MEN'S MINOXIDIL HAIR REGROWTH SYSTEM 5% MINOXODIL TOPICAL SOLUTION, USP Reactivates hair follicles to stimulate regrowth Clinically proven to help regrow hair Topical Solution Unscented Minoxidil Topical Solution 5% is for men who have a general thinning of hair on the top of the scalp (vertex only, as shown). Not intended for frontal baldness or a receding hairline. Minoxidil Topical Solution 5% has been shown to regrow hair in men with the following degrees of thinning hair of hair loss If men have more hair loss or hair loss in a place different than shown above, Minoxidil Topical Solution 5% may not work. Two month supply Two 60 ml (2 fl oz) bottles PRINCIPAL DISPLAY PANEL - 2-60 ml Bottle Dropcard
PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Shampoo COMPLIMENTS OF TOPIX PHARMACEUTICALS, INC Strengthening Basil Root Shampoo HAIR GROWTH SYSTEM Clean | Volumize | Strengthen Net 6.7 fl. oz. (200 ml) Available Custom Branded 800.445.2595 [email protected] PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Shampoo
PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Conditioner COMPLIMENTS OF TOPIX PHARMACEUTICALS, INC Rejuvenating Basil Root Conditioner HAIR GROWTH SYSTEM Condition | Volumize | Rejuvenate Net 6.7 fl. oz. (200 ml) Available Custom Branded 800.445.2595 [email protected] PRINCIPAL DISPLAY PANEL - 200 ml Bottle Label-Conditioner
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
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 you are a woman your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline you have no family history of hair loss your hair loss is sudden and/or patchy 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, 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.
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 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. 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 all men.
Pregnancy or breast feeding
Pregnancy or Breast feedingMay be harmful if used when pregnant or breast-feeding.
Storage and handling
Information about safe storage and handling of the drug product.Other information see hair loss pictures on opposite side before use, read all information on carton and enclosed leaflet keep the insert. It contains important information. 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 in clinical studies of mostly white men aged 18-49 years with moderate degrees of hair loss, 5% minoxidil topical solution for men provided more hair regrowth than 2% minoxidil topical solution store at controlled room temperature 20º to 25ºC (68º to 77ºF).
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 Do not use if you are a woman your amount of hair loss is different than that shown on the side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical solution is not intended for frontal baldness or receding hairline you have no family history of hair loss your hair loss is sudden and/or patchy 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, 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. 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 all men. 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 breast-feeding. 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