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| Product NDC Code | 84454-001 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | 5% minoxidil and 5% rosemary for hair care |
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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 | LIQUID | ||||||||
| Application Number | M032 | ||||||||
| Labeler Name | TIKNOW LLC | ||||||||
| 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.ACTIVE INGREDIENT 5% Minoxidil.........Hair regrowth treatment 5% Rosemary...........Anti-hair loss
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.DOSAGE & ADMINISTRATION Apply 1 ml with dropper 2 times a day.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT Water, Propylene Glycol, Butylene Glycol, Panthenol, Whitegrass Leaf/Root Extract, Dandelion Leaf Extract, Hawthorn Extract, Hydroxyacetophenone, 1.2-Hexanediol Sodium Edta, Peg-40 Hydrogenated Castor Oil, Fragrance
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.HOW TO USE 1. Apply 1ml with dropper 2 times a day directly onto the scalp in the hair loss area. 2. Use fingertips to massage solution into skin/hair for 2-3 minutes. 3. Using more or more often will not improve results.
Purpose
Information about the drug product’s indications for use.DESCRIPTION Use: To regrow hair of scalp and beard
Spl product data elements
Usually a list of ingredients in a drug product.5% Minoxidil and 5% Rosemary for Hair Care Minoxidil PROPYLENE GLYCOL WATER ROSEMARY ROSEMARY HYDROXYACETOPHENONE PEG-40 CASTOR OIL BUTYLENE GLYCOL PANTHENOL MINOXIDIL MINOXIDIL
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.84454-001-01, 84454-001-02, 84454-001-06 label
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: 5% Minoxidil topical solution is not intended for frontal baldness or receding hairline. You have family history of hair loss. Your hair loss is sudden and/or patchy You are under 18 yearrs of age.Do not use on babies and children. Your scalp is red, inflamed, infected, 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 KEEP OUT OF REACH OF CHILDREN
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: 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 regroth is different for each person.
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. Avoild contact with eyes. Please keep it out of reach of children. Store at controlled room temperature 66°-77°F (20°-25℃).
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