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Antibacterial coconut water aloe and vitamin e - Medication Information

Product NDC Code 50157-516
Drug Name

Antibacterial coconut water aloe and vitamin e

Type Brand
Active Ingredients
Benzalkonium chloride 1.3 mg/ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1046593
Application Number part333A
Labeler Name Brands International Corporation
Packages
Package NDC Code Description
50157-516-10 1000 ml in 1 bottle, plastic (50157-516-10)
50157-516-23 236 ml in 1 bottle, plastic (50157-516-23)
50157-516-37 3780 ml in 1 bottle, plastic (50157-516-37)
50157-516-44 443 ml in 1 bottle, plastic (50157-516-44)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Benzalkonium Chloride - 0.13%

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 occasional and personal domestic use Supervise children when they use this product. Lather in hands with water for at least 30 seconds. Rinse well.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Lauramidopropylamine oxide, Lauryl Glucoside, PEG-150 distearate, Glycol Stearate, Perfume, PEG-7 glycerly cocoate, Cetrimonium Chloride, Citric Acid, Glycerin, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Isopropyl myristate, Tocopheryl Acetate

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.
Effective in destroying (harmful) bacteria to provide antiseptic cleansing

Purpose

Information about the drug product’s indications for use.
Purpose - Antiseptic Skin cleanser

Spl product data elements

Usually a list of ingredients in a drug product.
Antibacterial Coconut Water Aloe and Vitamin E Benzalkonium Chloride CITRIC ACID MONOHYDRATE WATER CETRIMONIUM CHLORIDE ISOPROPYL MYRISTATE GLYCOL STEARATE LAURAMIDOPROPYLAMINE OXIDE PEG-7 GLYCERYL COCOATE DITETRACYCLINE TETRASODIUM EDETATE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF PEG-150 DISTEARATE LAURYL GLUCOSIDE BENZALKONIUM CHLORIDE BENZALKONIUM

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.
9 10 11 12

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.
Store below 59F-86F May discolor certain fabrics or 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 irritation or redness develops

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. If contact occurs, rinse eye thoroughly with water

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

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