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Berberex wound cleanser - Medication Information

Product NDC Code 52261-0500
Drug Name

Berberex wound cleanser

Type Brand
Active Ingredients
Allantoin 5 g/1000ml
Benzethonium chloride 1 g/1000ml
Route TOPICAL
Dosage Form LIQUID
RxCUI drug identifier 1437628,
1487627
Application Number part333A
Labeler Name Cosco International, Inc.
Packages
Package NDC Code Description
52261-0500-1 118 ml in 1 bottle, spray (52261-0500-1)
52261-0500-2 237 ml in 1 bottle, spray (52261-0500-2)
52261-0500-3 473 ml in 1 bottle, spray (52261-0500-3)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient/Purpose Allantoin 0.5%........................Skin Protectant Benzethonium Chloride............Antiseptic Uses helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips topical antiseptic to help decrease the risk of skin infections

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: Adults and children 2 years of age and older: use to clean minor cut, scrapes, and burns by thoroughly flushing the affected area let air dry cover with adhesive bandage or sterile gauze apply a small amount of this product on the area 1 to 3 times daily Children under 2 years of age: do not use, consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients: Aloe barbadensis Mill, Ethanol, Hydrastis canadensis L., Hydrogen Peroxide, Panax quinquefolis L., Water

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.
Do not use in large quantities, particularly over raw surfaces or blistered areas

Purpose

Information about the drug product’s indications for use.
Uses helps protect skin and supports healing of minor cuts, scrapes, burns and wounds, including pressure sores, diabetic ulcers, cracked skin and lips topical antiseptic to help decrease the risk of skin infections

Spl product data elements

Usually a list of ingredients in a drug product.
BerbereX Wound Cleanser Benzethonium Chloride ALLANTOIN ALLANTOIN BENZETHONIUM CHLORIDE BENZETHONIUM water ALCOHOL ALOE VERA WHOLE HYDRASTIS CANADENSIS WHOLE PANAX QUINQUEFOLIUS WHOLE hydrogen peroxide

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.
118 mL PLPLDP 237 mL PLPLDP 473 mL PLPLDP

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask doctor before use if you have deep or puncture wounds animal bites serious burns

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 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 doctor if condition worsens symptons persist for more than 7 days or clear up and occur again within a few days

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