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| Product NDC Code | 84614-003 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | 5% minoxidil hair growth foam with biotin |
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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 | AEROSOL, FOAM | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | Shenzhen Ctrip Technology Co., Ltd. | ||||||
| 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 5% Biotin 0.5%
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.1.Shake the bollle, hold it upside down and genlly press the walve to dispensefoam onio your hand, approximalely the size of half a capful 2.Massage the foam inio your gcalp with your fngers, paring your hair intorows to ensure even application to areas with thinning hair. Then, wash yourhands thoroughly. 3.Use Twice Daily and enjoy thicker, fuler hair gronth in as lille as 3 to 6months.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.ALCOHOL GLYCERIN CETYL ALCOHOL STEARYL ALCOHOL POLYSORBATE 80 ANHYDROUS CITRIC ACID LACTIC ACID CASTOR OIL .ALPHA.-TOCOPHEROL EDETATE DISODIUM ISOBUTANE BUTANE 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 of the scalp
Purpose
Information about the drug product’s indications for use.Hair Regrowih Treaiment
Spl product data elements
Usually a list of ingredients in a drug product.5% Minoxidil Hair Growth Foam with Biotin Minoxidil BIOTIN BIOTIN BUTANE ALCOHOL ANHYDROUS CITRIC ACID LACTIC ACID CETYL ALCOHOL GLYCERIN STEARYL ALCOHOL POLYSORBATE 80 .ALPHA.-TOCOPHEROL ISOBUTANE WATER MINOXIDIL MINOXIDIL CASTOR OIL EDETATE DISODIUM
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 label
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.5% Minoxidil Hair Growth Foam with Biotin
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.Your hair loss is gudden andlor palchy. Your hair loss is associald with chidbinth. You do nol knaw the reason for your hair logs. You are under 18 years of age. Do not use on babies and children. Your gcalp is red, intamed, infecled, irritated, or painfu. 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.lf swalkwed, get medical help or contac a Poison Conlrol Cenler(1-800-222-1222) 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.Chest pain, rapid hearibeat, aininegs, or dizziness oocurs. Sudden, unexplained weight gain oocurs. If umwaneed facil har growth occurs . lf you do nat see hair regrowth in 6 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.Awoid contact with the eyes. in case of accidenlal conlact, rinse eyes withlarge amcunts of cool tap waler. Some people have experienced changes in hair color andlor lexture. It takes time lo regrow hair, Resuts may ooour at 3 monihs with twice a dayusage. For some men, you may need to use this product for at least 6 monlhsbefore you see results. The amount of hair regrowih is diferent for eachpergon. Awoid contact with eyes. in case of aocidenlal contact, rinse eyes with alarge amcunt of cool tap waler.
Storage and handling
Information about safe storage and handling of the drug product.Before use, read al informglion on carton and enclosed leale.Store at conlrolled room temperalure 20° lo 25°℃ (68° to 77°F)Do not incinerale container. Do not expose to heat or slore at lemperalureabove 104° F(40°C).
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.Flammable:keep away from fire or flame. Keep out of reach of children. For exlernal use oniy
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