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| Product NDC Code | 83619-001 | ||||||||||||||||
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| Drug Name | Wart remover |
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| Type | Generic | ||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||
| Dosage Form | LIQUID | ||||||||||||||||
| Application Number | M028 | ||||||||||||||||
| Labeler Name | Shenzhen Derbit Technology 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 ingredient Chinese rehmannia ( REHMANNIACHINENSIS ) root extract 3% Sophora flavescens ( SOPHORAFLAVESCENS ) extrac 3% White Willow ( SALIX ALBA ) BarkExtract 2% Acetic acid 1% Keratin 0.5% Impatiens balsamina flowerextract 3% White fresh ( DICTAMNUSDASYCARPUS ) root bark extract 2% Panax notoginseng ( PANAXNOTOGINSENG ) extract 2%
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.Direction Spread the product over the nail fungus andwait for the product to be absorbed .When using this product , supervise childrenunder 6 years of age to avoid swallowing .Other Information ( Storage and ProcessingSection ) Edit Store at 10-30 ( 59-86F )
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.inactive ingredients Water , Glycerin , Xanthan Gum, Methylparaben , Caprylyl Hydroxamic Acid
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 Reduces fungal infections on nailsand helps restore nails to health.
Purpose
Information about the drug product’s indications for use.purpose enhance skin metabolism antibacterial andanti-inflammatory Anti-inflammatory reduce fungalinfection promote nailgrowth promoting bloodcirculation and relieving pain antipruritic stopbleeding, enhance immunity
Spl product data elements
Usually a list of ingredients in a drug product.WART REMOVER WART REMOVER SALIX ALBA BARK SALIX ALBA BARK IMPATIENS BALSAMINA FLOWER IMPATIENS BALSAMINA FLOWER CAPRYLHYDROXAMIC ACID REHMANNIA GLUTINOSA ROOT REHMANNIA GLUTINOSA ROOT ACETIC ACID ACETIC ACID AMINO ACIDS, HAIR KERATIN AMINO ACIDS, HAIR KERATIN DICTAMNUS DASYCARPUS ROOT BARK DICTAMNUS DASYCARPUS ROOT BARK PANAX NOTOGINSENG ROOT PANAX NOTOGINSENG ROOT WATER GLYCERIN XANTHAN GUM SOPHORA FLAVESCENS ROOT SOPHORA FLAVESCENS ROOT METHYLPARABEN
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.83619-001-01
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 Do not use under open wounds
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 this product out of the reach ofchildren. If swallowed, get medical help orcontact 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.OTC-STOP USE SECTION If irritation or rash occurs, discontinue useand ask a doctor. These may be signs of a serious condition.
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 SECTION When using this product, keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water. If irritation or rash occurs, discontinue use and ask a doctor. These may be signs of a serious condition Please keep this product out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other Information ( Storage and Processing Section ) Edit Store at 10-30 ( 59-86F )
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.Warning For external use only, do not consume
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