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NDC 52083-0242-30 Myco Nail A Antifungal Solution 250 mg/mL Details
Myco Nail A Antifungal Solution 250 mg/mL
Myco Nail A Antifungal Solution is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Kramer Novis. The primary component is UNDECYLENIC ACID.
Product Information
| NDC | 52083-0242 |
|---|---|
| Product ID | 52083-242_72c48d04-90db-4af0-bc88-3b28f949a04b |
| Associated GPIs | 90150095002025 |
| GCN Sequence Number | 021734 |
| GCN Sequence Number Description | undecylenic acid SOLUTION 25 % TOPICAL |
| HIC3 | Q5F |
| HIC3 Description | TOPICAL ANTIFUNGALS |
| GCN | 42543 |
| HICL Sequence Number | 005242 |
| HICL Sequence Number Description | UNDECYLENIC ACID |
| Brand/Generic | Generic |
| Proprietary Name | Myco Nail A Antifungal Solution |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Undecylenic acid |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | TOPICAL |
| Active Ingredient Strength | 250 |
| Active Ingredient Units | mg/mL |
| Substance Name | UNDECYLENIC ACID |
| Labeler Name | Kramer Novis |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333C |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 52083-0242-30 (52083024230)
| NDC Package Code | 52083-242-30 |
|---|---|
| Billing NDC | 52083024230 |
| Package | 1 BOTTLE in 1 CARTON (52083-242-30) / 30 mL in 1 BOTTLE |
| Marketing Start Date | 2014-01-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 550358d7-69e8-4ea3-bcf9-d647c457287d Details
Uses
Warnings
For external use only. Flammable: Keep away from fire and flame.
When using this product avoid contact with the eyes and mucuos membranes.
Stop use and ask a doctor if irritation occurs or is there is no improvement within 4 weeks.
Directions
Clean the affected area and dry thoroughly. Apply a thin layer of Myco Nail A over the affected area twice daily (morning and night) or as directed by a physician. Supervise children in the use of this product. For athlete's foot: pay special attention to spaces between toes; wear well-fitted, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a physcian.
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton
INGREDIENTS AND APPEARANCE
| MYCO NAIL A ANTIFUNGAL SOLUTION
undecylenic acid liquid |
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| Labeler - Kramer Novis (090158395) |
| Registrant - Kramer Novis (090158395) |