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| Product NDC Code | 53863-002 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Hand sanitizer |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | GEL | ||||||||||||
| RxCUI drug identifier | 581662 | ||||||||||||
| Application Number | 505G(a)(3) | ||||||||||||
| Labeler Name | Exelencia Importers, Corp. | ||||||||||||
| 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 Ethyl Alcohol 70% v/v. Purpose: Antiseptic
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 Wet hands thoroughly with product and allow to dry. Children under 6 years of age, use only under adult supervision.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Carbomer, Triethanolamine, Fragrance (Parfum), Phospholipids, Polyquaternium-16, BHT, Panthenol, Niacinamide, Dimethicone, Bisabolol, Phenoxyethanol, Tocopheryl Acetate, CI 16035 Fromsoybean lecithin. FD&C RED 40.
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 Decreases bacteria on skin that pontetially can cause disease Recommended for repeated use.
Purpose
Information about the drug product’s indications for use.Purpose Antiseptic, Hand Sanitizer
Spl product data elements
Usually a list of ingredients in a drug product.Hand Sanitizer Ethyl Alcohol POLYQUATERNIUM-16 (N-VINYLPYRROLIDINONE:3-METHYL-1-VINYLIMIDAZOLIUM CHLORIDE (5:5)) BUTYLATED HYDROXYTOLUENE PANTHENOL EGG PHOSPHOLIPIDS DIMETHICONE PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE FD&C RED NO. 40 NIACINAMIDE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE TROLAMINE WATER LEVOMENOL 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.EXEL ALCOHOL EN GEL ANTIMICROBIANO con liposomas humectantes y suavizantes ALCOOL GEL ANTIMICROBIANO com lipossomas de acao humectante e suavizante HAND SANITIZER with moisturizing and softening liposomes BIOCOSMETICA PROFESIONAL 1.69 fl. Oz/50 ml e USA-490-TODOS-0720
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 children less than 2 months of age. On open skin wounds.
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Do not store above 105F (43C). May discolor some fabrics and surfaces.
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 redness or irritation develops & persits for more than 72 hours.
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, avoid contact with eyes, ears, and mouth. In case of contact with eyes flush thoroughly with water. Stop use and ask a doctor if redness or irritation develops & persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 When using this product, avoid contact with eyes, ears and mouth. In case of contact with eyes flush 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