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Product NDC Code | 84979-016 | ||||
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Drug Name | Hairline mask |
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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 | CUTANEOUS, EXTRACORPOREAL | ||||
Dosage Form | PASTE | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Guangdong Dazhan Biomedical Technology Co., Ltd | ||||
Packages |
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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.Ensure the scalp is clean and dry before application. Remove the adhesive backing from the patch and apply directly to the targeted area along the hairline. Press gently to secure the patch in place.
Clean and dry the area along the hairline before application. Remove the protective backing from the patch. Place the patch gently on the targeted area of thinning hair or receding hairline. Press down firmly to ensure proper adhesion.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.WATER GLYCERIN PANTHENOL NIACINAMIDE BIOTA ORIENTALIS LEAF EXTRACT IODOPROPYNYL BUTYLCARBAMATE POLYSORBATE 20 CAFFEINE PROPYLENE GLYCOL AZELAIC ACID BUTYLENE GLYCOL PEG-40 HYDROGENATED CASTOR OIL MENTHA HAPLOCALIX EXTRACT BORNEOL AROMA DISODIUM EDTA APIGENIN ACETYL TETRAPEPTIDE-3 BIOTIN OLEANOLIC ACID BIOTINOYL TRIPEPTIDE-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 and Usage For women: This product is intended to promote hair regrowth and reduce hair thinning along the hairline.
Purpose
Information about the drug product’s indications for use.Hair Regrowth Treatment Helps to promote hair regrowth and prevent further hair loss.
Spl product data elements
Usually a list of ingredients in a drug product.HAIRLINE MASK HAIRLINE MASK CAFFEINE BIOTIN GLYCERIN PANTHENOL MINOXIDIL MINOXIDIL BUTYLENE GLYCOL BORNEOL POLYSORBATE 20 WATER PEG-40 HYDROGENATED CASTOR OIL OLEANOLIC ACID IODOPROPYNYL BUTYLCARBAMATE APIGENIN AZELAIC ACID NIACINAMIDE
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
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 This product is not intended for use by children under 18 years of age. If swallowed, get medical help or contact a Poison Control Center immediately.
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 You experience: Severe scalp irritation, redness, or swelling. Unusual symptoms such as dizziness, fainting, or chest pain. Swelling in the hands or feet. Persistent or worsening hair loss after regular use. No improvement in hair regrowth is observed after 4 months of consistent use as directed. You develop an allergic reaction (e.g., rash, itching, or swelling). Hair loss occurs in patches, suddenly increases, or is accompanied by other medical symptoms.
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 Avoid contact with eyes. In case of accidental contact, rinse eyes thoroughly with water.
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