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Phoemay - Prescription Drug Labeling

Product NDC Code 81392-001
Drug Name

Phoemay

Type Brand
Active Ingredients
Benzalkonium chloride .00008 g/1001
Route TOPICAL
Dosage Form CLOTH
Application Number part333A
Labeler Name YIBIN HMEI KANGJIAN BIOTECHNOLOGY CO., LTD.
Packages
Package NDC Code Description
81392-001-01 80 cloth in 1 package (81392-001-01)

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient(s) Benzalkonium Chloride 0.00008%

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 Open the lid and tear the tape, takeout the production to wipe the skin to be cleaned. Please close the lid after use, to avoid moisture evaporation. Supervise children under 6 years of age when using this product to avoid swallowing.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Purified 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.
Use Open the lid and tear the patch, remove the product and wipe the skin to be cleaned as required.Please close the lid of the box after use to avoid evaporation of moisture.

Purpose

Information about the drug product’s indications for use.
Purpose Anticorrosion

Spl product data elements

Usually a list of ingredients in a drug product.
Phoemay Facial Cleaning Wipes WATER 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.
Package Label - Principal Display Panel 81392-001-01 80P 81392-001-01 80P

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.

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.
If allergic discomfort occurs, stop use and ask a doctor.

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, stop use and ask a doctor if you feel sensitive or unwell.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Storage and handling

Information about safe storage and handling of the drug product.
Other information Store in a cool, dry place away from direct sunlight.

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 This product is insoluble.Do not throw it into the toilet after use.

Disclaimer: Do not rely on openFDA 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