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Whitening cream - Medication Information

Product NDC Code 83872-191
Drug Name

Whitening cream

Type Generic
Active Ingredients
Arbutin 50 g/mg
Route TOPICAL
Dosage Form CREAM
Application Number 505G(a)(3)
Labeler Name Shenzhen Xiaomai Manufacturing Co Ltd
Packages
Package NDC Code Description
83872-191-01 50 mg in 1 bottle (83872-191-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT Arbutin

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 use Use twice daily, in the morning and evening. Apply an appropriate amount of cream evenly tothe cleansed face and neck. Gently massage until fully absorbed. Increase frequency of use as needed based onskin condition.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENT Arbutin Aqua Glycerin Sodium Hyaluronate Stearyl Alcohol Propanediol Hydrogenated Lecithin Squalane Retinol

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.
INDICATIONS whiten skin

Purpose

Information about the drug product’s indications for use.
PURPOSE whiten skin

Spl product data elements

Usually a list of ingredients in a drug product.
whitening cream whitening cream PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER ISOSTEARYL ALCOHOL SQUALANE DIGLYCERIN ALISMA PLANTAGO-AQUATICA ROOT 22-HYDROGENATED RACEMIC CALCIPOTRIOL ARBUTIN ARBUTIN 2-(1-CHLOROCYCLOPROPYL)-3-(2-CHLOROPHENYL)-1,2-PROPANEDIOL RETINOL

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.
label label

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. Keep out of reach of children.

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.
Do not use Do not use on damaged or brokenskin. Stop use and ask a doctor Stop use and ask a doctor if rash occurs

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 Wnen using tnis product keep out of eyes. Rinse with water to remove.

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Store in a cool, dry place. "Avoid direct sunlight. Consult a dermatologist if you have any questions.

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