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Product NDC Code | 83566-155 | ||||||||||||
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Drug Name | Gze skincare oil |
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Type | Brand | ||||||||||||
Pharm Class | Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Plant Proteins [CS], Pollen [CS], Seed Storage Proteins [CS] |
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Active Ingredients |
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Route | TOPICAL | ||||||||||||
Dosage Form | LIQUID | ||||||||||||
Application Number | M016 | ||||||||||||
Labeler Name | Guangzhou Yilong Cosmetics Co.,Ltd. | ||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Helianthus Annuus(Sunflower) Seed Oil 5% Tocopheryl Acetate 5% Anthemis Nobilis Flower Oil 3.1% Lavandula Angustifolia(Lavender) Oil 2.4% Rosmarinus Officinalis(Rosemary)Leaf Oil 1% Calendula Officinalis Extract 1%
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.Massage into the skin for 30 or more seconds until the oil has absorbed.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.TRIISONONANOIN CETEARYL ETHYLHEXANOATE DIRECT RED 17 MINERAL OIL SOYBEAN OIL .BETA.-BISABOLOL EUGENOL GERANIOL PARFUMIDINE ISOPROPYL MYRISTATE
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 Massage into the skin for 30 ormore seconds until the oil has absorbed.
Purpose
Information about the drug product’s indications for use.Purpose Moisturizing
Spl product data elements
Usually a list of ingredients in a drug product.GZE Skincare Oil Vitamin E SUNFLOWER SEED SUNFLOWER SEED ROSEMARY OIL ROSEMARY OIL TRIISONONANOIN ANTHEMIS COTULA POLLEN ANTHEMIS COTULA POLLEN CALENDULA OFFICINALIS WHOLE CALENDULA OFFICINALIS WHOLE CETEARYL ETHYLHEXANOATE DIRECT RED 17 LAVENDER OIL LAVENDER OIL MINERAL OIL SOYBEAN OIL .BETA.-BISABOLOL EUGENOL GERANIOL PARFUMIDINE ISOPROPYL MYRISTATE TOCOPHERYL RETINOATE TOCOPHERYL RETINOATE
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
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 on damaged or broken skin.
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.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 keep out of eyes. Rinse with water to remove.
Safe handling warning
Safe Handling WarningWarnings For external use only.
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.For external use only.
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