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Product NDC Code | 83872-524 | ||||
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Drug Name | Kojic acid |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SOAP | ||||
Application Number | 505G(a)(3) | ||||
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 Kojic Acid
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 1.Wet the skin: Moisten your face or body with warm water. 2.Lather the soap: Rub the soap to create foam. 3.Gently massage: Apply the foam to your skin and massage gently for 1-2 minutes, focusing on areas with dark spots or uneven tone. 3.Rinse thoroughly: Wash off with warm water to remove all the foam. 4.Moisturize: Apply a moisturizer afterward to lock in hydration and protect the skin barrier.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alkyl Polyglucoside (ApG), Glycerin, Decyl Glucoside, Ascorbic Acid(Vitamin c),Retinol, Kojic Acid, Collagen, Hyaluronic Acid,TurmericPE, Sodium ChlorideAqua, Shea Butter Vitamin E,Olive Oil, Fra-grance, FD&C Yellow, FD&C Red
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 Cleanse the skin
Purpose
Information about the drug product’s indications for use.Purpose Cleanse the skin
Spl product data elements
Usually a list of ingredients in a drug product.Kojic Acid Soap KOJIC ACID KOJIC ACID RETINOL TURMERIC OLIVE OIL AQUA GLYCERIN DECYL GLUCOSIDE HYALURONIC ACID SODIUM CHLORIDE SHEA BUTTER ASCORBIC ACID
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.PRINCIPAL DISPLAY PANEL LBEAL
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 Wif swallowed
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 For external use onlyDo not use on damaged or broken skinWhen using this product keep out of eyes.
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 Chlidren Keep Out Of Reach Of Chlidren
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 "chest pain, rapid heart beat.faintness, or dizziness occurs sudden, unexplained weight gain occurs. your hands or feet swell scalp imitation or redness occurs May be harmful if used when pregnant or breast-feeding Keep Out Of Reach Of Chlidren: if swallowed,get medical help 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 Do not use on damaged or broken skinWhen using this product keep out of eyes.Rinse with water to remove.Stop use and ask a doctor if rash occursKeep out of reach of children. If swallowed, get medical help or contact a PoisonControl Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information Please 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 "-For external use only -Keep away from fire and flame"
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