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| Product NDC Code | 72222-224 | ||||
|---|---|---|---|---|---|
| Drug Name | Remedy nails |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part333C | ||||
| Labeler Name | Adwill Labs 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.ACTIVE INGREDIENT: Undecylenic Acid USP 10%
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: Wash and dry affected area. Apply a thin layer over affected area twice daily or as directed by a doctor. Apply enough medication to cover the affected area and surrounding skin. Wash hands after use. For maximum results, use twice daily or as instructed. Discontinuing use of this medication may allow recurrence of infection. If condition persists, consult your doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Mineral Oil, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Oil, Linalool, Carthamus Tinctorius (Safflower) Seed Oil, Limonene, Aleurites Moluccana (Kukui) Seed Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Algae Extract.
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: Treats cuticle and skin fungal infections. Heals and moisturizes cuticles and skin. Athlete's foot treatment. Relieves itching, burning and cracking.
Purpose
Information about the drug product’s indications for use.PURPOSE: Anti-Fungal
Spl product data elements
Usually a list of ingredients in a drug product.Remedy Nails Undecylenic Acid MINERAL OIL ISOPROPYL MYRISTATE SAFFLOWER OIL TEA TREE OIL GRAPE SEED OIL .ALPHA.-TOCOPHEROL ACETATE LAVENDER OIL 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 - 15 mL Bottle Label Dr.'s REMEDY ® Therapeutic Cuticle Oil Lavender Safflower Tea Tree Oil Algae Extract Nourishing Anti-Fungal Treatment 15mL Principal Display Panel - 15 mL Bottle Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.CAUTION: Do not accept if safety seal is broken or missing. Store at room temperature 60-85F. Keep in tight, light resistant container.
ALLERGIC REACTIONS: Contact doctor if unusual reactions to this medicine occur. This product does not contain FD&C Yellow #5 or FD&C Yellow #6.
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. Consult your doctor if you are pregnant before using this product. It is not known whether this drug passes into breast milk. Consult your doctor before breast feeding. If swallowed, call Poison Control Center immediately.
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: Irritation occurs. No improvement within 2 weeks.
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. Keep out of reach of children. Consult your doctor if you are pregnant before using this product. It is not known whether this drug passes into breast milk. Consult your doctor before breast feeding. If swallowed, call Poison Control Center immediately.
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