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| Product NDC Code | 52261-5800 | ||||
|---|---|---|---|---|---|
| Drug Name | Botanimedix onychorx antifungal nail gel |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | GEL | ||||
| RxCUI drug identifier | 1362039 | ||||
| Application Number | part333C | ||||
| Labeler Name | Cosco International, Inc. | ||||
| 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.DRUG FACTS Active Ingredient Purpose Undecylenic Acid 25%........................Anti-fungal
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: Apply twice daily for best results.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Alpha Tocopheryl Acetate (Vitamin E), Cannabidiol, Cetostearyl Alchohol, Clove Leaf Oil, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Oil, Glyceryl Monostearate, Hypromellose, Isopropyl Palmitate, Peppermint Oil, Phenoxyethanol, Polysorbate 60, Propolis Wax, Tea Tree Oil, Urea, Water
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.For relief of: Itching, Burning, Redness, Irratation, Scaling, Soreness Discomfort which may accompany these conditions
Purpose
Information about the drug product’s indications for use.Uses: For the cure of most Tinea Pedis (athlete's foot) and Tinea Corporis (ringworm) For relief of: Itching, Burning, Redness, Irratation, Scaling, Soreness Discomfort which may accompany these conditions
Spl product data elements
Usually a list of ingredients in a drug product.Botanimedix OnychoRX Antifungal Nail Gel Undecylenic Acid UNDECYLENIC ACID UNDECYLENIC ACID ISOPROPYL PALMITATE CETOSTEARYL ALCOHOL POLYSORBATE 60 GLYCERYL MONOSTEARATE UREA PEPPERMINT OIL .ALPHA.-TOCOPHEROL ACETATE, DL- PROPOLIS WAX HYPROMELLOSE 2208 (15000 MPA.S) WATER TEA TREE OIL EUCALYPTUS OIL PHENOXYETHANOL ETHYLHEXYLGLYCERIN CANNABIDIOL CLOVE LEAF OIL DIMETHYL SULFOXIDE
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
carton
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call: 1-800-964-5406 www.botanimedix.com
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: Condition worsens. Symptoms last more than 7 days or clear and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Inactive Ingredients: Alpha Tocopheryl Acetate (Vitamin E), Cannabidiol, Cetostearyl Alchohol, Clove Leaf Oil, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Oil, Glyceryl Monostearate, Hypromellose, Isopropyl Palmitate, Peppermint Oil, Phenoxyethanol, Polysorbate 60, Propolis Wax, Tea Tree Oil, Urea, Water Questions? Call: 1-800-964-5406 www.botanimedix.com Distributed by: BotaniMedix Atlanta, GA 30067
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 Do not get into eyes. Stop use and ask a doctor if: Condition worsens. Symptoms last more than 7 days or clear and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Inactive Ingredients: Alpha Tocopheryl Acetate (Vitamin E), Cannabidiol, Cetostearyl Alchohol, Clove Leaf Oil, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Oil, Glyceryl Monostearate, Hypromellose, Isopropyl Palmitate, Peppermint Oil, Phenoxyethanol, Polysorbate 60, Propolis Wax, Tea Tree Oil, Urea, Water Questions? Call: 1-800-964-5406 www.botanimedix.com Distributed by: BotaniMedix Atlanta, GA 30067
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. When using this product Do not get into eyes. Stop use and ask a doctor if: Condition worsens. Symptoms last more than 7 days or clear and occur again within a few days. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Inactive Ingredients: Alpha Tocopheryl Acetate (Vitamin E), Cannabidiol, Cetostearyl Alchohol, Clove Leaf Oil, Dimethyl Sulfoxide, Ethylhexylglycerin, Eucalyptus Oil, Glyceryl Monostearate, Hypromellose, Isopropyl Palmitate, Peppermint Oil, Phenoxyethanol, Polysorbate 60, Propolis Wax, Tea Tree Oil, Urea, Water Questions? Call: 1-800-964-5406 www.botanimedix.com Distributed by: BotaniMedix Atlanta, GA 30067
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