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| Product NDC Code | 83872-199 | ||||
|---|---|---|---|---|---|
| Drug Name | Whitening cream |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | EXTRACORPOREAL, TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | 505G(a)(3) | ||||
| Labeler Name | Shenzhen XiaoMai Manufacturing Co., Ltd. | ||||
| 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 Arbutin 3%
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 Apply once in the morning and once in the evening; adjust frequency as needed based on skin condition.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT Aqua 68% Glycerin 8% Sodium Hyaluronate 1.5% Stearyl Alcohol 2% Propanediol 5% Hydrogenated Lecithin 1.5% Squalane 10% Retinol 1%
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 Used to brighten skin tone and reduce dark spots for a more even and luminous complexion.
Purpose
Information about the drug product’s indications for use.PURPOSE Primarily used to improve uneven skin tone and reduce dark spots, making the skin look brighter and more even.
Spl product data elements
Usually a list of ingredients in a drug product.whitening cream whitening cream SQUALANE PROPANEDIOL STEARYL ALCOHOL WATER GLYCERIN RETINOL ARBUTIN ARBUTIN
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. Apply once in the morning and once in the evening; adjust frequency as needed based on skin condition.
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 keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor If swallowed, get medicalhelp or contact a Poison Control Center right away.
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 if rash occurs.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Store in a cool, dry place, avoid 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 on damaged or broken skin.
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