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Product NDC Code | 83872-122 | ||||
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Drug Name | Dark spot corrector cream |
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Type | Generic | ||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M016 | ||||
Labeler Name | Shenzhen XiaoMai Manufacturing Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT Collagen: 5.0% Active Pigment Concentrate: 2.0% Glycerin: 5.0%
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 1. Apply the product to clean face and neck. 2.Gently massage until fully absorbed. 3.Use twice daily as part of your daily skincare routine.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT Aqua (Water): 70.0% Cetearyl Alcohol: 3.0% Stearic Acid: 3.0% Caprylic/Capric Triglyceride: 10.0% Phenoxyethanol: 2.0%
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.Uses Dark spots and pigmentation.
Purpose
Information about the drug product’s indications for use.PURPOSE Used to reduce dark spots and pigmentation.
Spl product data elements
Usually a list of ingredients in a drug product.dark spot corrector cream dark spot corrector cream GLYCERIN GLYCERIN WATER STEARIC ACID PHENOXYETHANOL
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.5
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 on damaged or broken skin.
Stop use and ask a doctor Discontinue use if irritation 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 keep out of eyes. Rinse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.Store in a cool, dry place away from direct sunlight and heat. Keep packaging intact.
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. Avoid contact with eyes.
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