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Product NDC Code | 83872-526 | ||||
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Drug Name | Peppermint |
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Type | Brand | ||||
Pharm Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS] |
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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 ingredients Peppermint Leaf Extract
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Do not use Do not use on damaged or broken skin
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: Wet the cleaned area with warm water. 2. Lather: Rub the soap into a foaming foam, or use a foaming net to create foam. 3. Cleanse: Gently massage the skin with the foam, avoiding direct friction. 4. Rinse: Rinse the foam thoroughly with warm water. 5. Dry: Pat dry with a towel and apply moisturizer (if needed).
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Coconut Oil, Palm Oil, Olive Oil, Peppermint Essential Oil, Peppermint Leaf Extract, Baking Soda, Burdock Root Extract, Vitamin E .
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 Cleansing the skin,keeping skin hydrated, soft and smooth, moisturizes
Purpose
Information about the drug product’s indications for use.Purpose Cleansing the skin,keeping skin hydrated, soft and smooth, moisturizes
Spl product data elements
Usually a list of ingredients in a drug product.Peppermint Soap PALM OIL PEPPERMINT OIL PEPPERMINT PEPPERMINT OLIVE OIL COCONUT OIL
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 or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask Doctor When Pregnant or breast-feeding.
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.If swallowed, get medical help or contacta 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 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 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.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 Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children.If swallowed, get medical help or contacta Poison Control Center right away."
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