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Product NDC Code | 11928-004 | ||||
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Drug Name | Mada |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | GEL | ||||
RxCUI drug identifier | 581660 | ||||
Application Number | 505G(a)(3) | ||||
Labeler Name | Mada Medical Products, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Ethyl Alcohol 62% v/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 To decrease bacteria on skin, apply a small amount to palm. Briskly rub,covering hands with product until dry.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol
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.Uses For hand cleaning to decrease bacteria on skin.
Purpose
Information about the drug product’s indications for use.Purpose Antibacterial Agent
Spl product data elements
Usually a list of ingredients in a drug product.Mada Alcohol WATER GLYCERIN PROPYLENE GLYCOL ISOPROPYL MYRISTATE ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE CARBOXYPOLYMETHYLENE AMINOMETHYLPROPANOL ALCOHOL ALCOHOL
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.MadaGel Instant Hand Sanitizer with Moisturizers Broad Spectrum Antimicrobial Effectiveness Kills 99.9% of common bacteria in seconds without using water. 4 Fl. Oz. (118ml) container 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 in eyes. In case of contact, rinse thoroughly.
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, contact a physician or poison control center.
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 irritation and redness appears and lasts.
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. FLAMMABLE Keep away from heat or flame. Do not use in eyes. In case of contact, rinse thoroughly. Stop use and ask a doctor if irritation and redness appears and lasts. Keep out of reach of children. If swallowed, contact a physician or poison control center.
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