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Product NDC Code | 83872-184 | ||||
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Drug Name | Hair growth serum unique formula |
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Type | Generic | ||||
Pharm Class | Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC] |
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Active Ingredients |
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Route | EXTRACORPOREAL, TOPICAL | ||||
Dosage Form | LIQUID | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Shenzhen XiaoMai Manufacturing Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Minoxidil: Minoxidil Biotin: Biotin
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 for use 1. Apply 1 ML(few drops) directly onto scalp on the hairloss area. 2. Use fingertips to massage solution into skin/hair for2-3 minutes. 3. Allow time for hair to fully absorb Growth Oil For bestresults, use twice daily on clean dry hair.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT Aqua (Water): 54.8% Alcohol Denat: 10% Propylene Glycol: 15% Butylene Glycol: 5% PEG-40 Hydrogenated Castor Oil: 5% Polysorbate 20: 3% Phenoxyethanol: 1% Ethylhexylglycerin: 1%
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.INDICATIONS Use to regrow hair on the top of the scalp.
Purpose
Information about the drug product’s indications for use.PURPOSE Hair Regrowth
Spl product data elements
Usually a list of ingredients in a drug product.HAIR GROWTH SERUM UNIQUE FORMULA HAIR GROWTH SERUM UNIQUE FORMULA PHENOXYETHANOL POLYSORBATE 20 BIOTIN BIOTIN MINOXIDIL MINOXIDIL WATER BUTYLENE GLYCOL ETHYLHEXYLGLYCERIN
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
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.Do not use You have no family history of hair loss,hair loss is sudden and/or patchy. You do not know the reason for you hair loss. You ae under 18 years of age, Do not use it 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 hace heart disease.
Stop use and ask a doctor Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.
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 to other parts of the body, void contact with eyes, In case of accidental contact, rinse eyes with a large amount of cool tap water. It takes time to regrow hair, You may need to usethis product 2 times a day for a least 4 monthsbefore you see results, The amount of hairregrowth is different for each preson.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Keep away from heat and direct sunlight Store in cool and dry place.
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 external use only Keep away from fire and 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