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| Product NDC Code | 84744-065 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Ximonth agarwood sleeping essential oil |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | OIL | ||||||
| Application Number | M014 | ||||||
| Labeler Name | Guangdong Ouhoe Biotechnology 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 INGREDIENTS LAVENDER OIL、ROSA X DAMASCENA FLOWER OIL、TOCOPHEROL
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.GLYCERIN、ALLANTOIN
Purpose
Information about the drug product’s indications for use.PURPOSE Gentle and comfortable to promote sleep; relax before bedtime; easily help you fall asleep peacefully
Spl product data elements
Usually a list of ingredients in a drug product.XIMONTH Agarwood Sleeping Essential Oil GLYCERIN LAVENDER OIL LAVENDER OIL ROSA X DAMASCENA FLOWER OIL ROSA X DAMASCENA FLOWER OIL ALLANTOIN GLYCERIN TOCOPHEROL TOCOPHEROL
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 Discontinue use if signs of irritation or rash occur.
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.Please keep out of reach of children. Do not swallow.
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 Discontinue use if signs of irritation or rash occur.
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.USE Before going to bed, roll the essential oil roller evenly on the body skin and gently massage for 3-5 minutes until absorbed.
Storage and handling
Information about safe storage and handling of the drug product.Store in a cool and dry place.
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 Please keep out of reach of children. Do not swallow.Please clean your hands before use to ensure the best results from the product. Discontinue use if signs of irritation or rash occur. Store in a cool and dry place.
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