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| Product NDC Code | 55910-410 | ||||
|---|---|---|---|---|---|
| Drug Name | Undecylenic acid |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| RxCUI drug identifier | 998329 | ||||
| Application Number | M005 | ||||
| Labeler Name | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Undecylenic acid 25%w/w
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 Read all warnings and directions. Use only as directed. clean the affected area and dry thoroughly apply a thin layer of the product over the affected area twice daily (morning and evening) or as directed by a doctor supervise children in the use of this product for athlete's foot: pay special attention to spaces between the toes wear well- fitting, ventilated shoes, and changes shoes and socks atleast once daily for athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor. this product is not effective on the scalp or nails
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient isopropyl palmitate
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 For cure of most tinea pedis (athete's foot) and tinea corporis (ringworm) For relief of: discomforts which may accompany these conditons itching burning redness irritation scaling soreness
Purpose
Information about the drug product’s indications for use.Purpose Antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Undecylenic Acid Anti-Fungal Nail Solution ISOPROPYL PALMITATE UNDECYLENIC ACID UNDECYLENIC ACID
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 DG Health Maximum Strength Anti-Fungal Nail Solution Undecylenic Acid 25% Eliminates fungus on fingers, toes and around nails Easy to apply appliator brush Dries quickly Non-oily, clear formula No unpleasant odor Net Contents 1 FL OZ (30 mL) Dollar General Antifungal Nail Solution Box 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 children under 2 years of age unless directed by the doctor.
Instructions for use
Information about safe handling and use of the drug product.use only as directed by the doctor on persons with highly sensitive 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 accidental ingestion occurs, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.other information store at room temperature 150 - 300C (590 - 860F) protect from freezing. If freezing occurs warm to room temperature keep tightly closed when not in use
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-866-964-0939
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 consult a doctor if there is no improvement within 4 weeks irritation 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 avoid contact with eyes.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breastfeeding consult a healthcare professional before use.
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. If pregnant or breastfeeding consult a healthcare professional before use. Do not use on children under 2 years of age unless directed by the doctor. When using this product avoid contact with eyes. use only as directed by the doctor on persons with highly sensitive skin. Stop use and consult a doctor if there is no improvement within 4 weeks irritation occurs Keep out of reach of children. If accidental ingestion occurs, get medical help or contact a 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