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NDC 63347-0200-01 Antifungal 4.8 mg/36.97mL Details
Antifungal 4.8 mg/36.97mL
Antifungal is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Blaine Labs Inc.. The primary component is UNDECYLENIC ACID.
Product Information
| NDC | 63347-0200 |
|---|---|
| Product ID | 63347-200_80736705-4909-41c6-8f0c-967b1fad94f9 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Antifungal |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | UNDECYLENIC ACID |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 4.8 |
| Active Ingredient Units | mg/36.97mL |
| Substance Name | UNDECYLENIC ACID |
| Labeler Name | Blaine Labs Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333C |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 63347-0200-01 (63347020001)
| NDC Package Code | 63347-200-01 |
|---|---|
| Billing NDC | 63347020001 |
| Package | 36.97 mL in 1 BOTTLE (63347-200-01) |
| Marketing Start Date | 2016-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ee5fa679-5c30-4432-885f-9fb8129a8460 Details
Keep out of reach of children
Indications:
Warnings:
Do not use on children under two years of age unless directed by a physician. For external use only. Avoid contact with eyes. If irritation occurs or if there is no improvement within four (4) weeks (for Athlete's Foot or Ringworm) or within two (2) weeks (for Jock Itch), discontinue use and consult a physician.
Directions:
Wash the affected area with soap and water and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night), or as directed by a physician. For Athlete's Foot, pay special attention to spaces between the toes; Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For Athlete's Foot and Ringworm, use daily for four (4) weeks. For Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician. Wash hands after each use.
Inactive Ingredients
Water, Urea, Hydroxyethylcellulose, Disodium EDTA, COCO Caprylate Caprate, Polysorbate 60, Cetyl Alcohol, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Aloe Bardadensis Leaf Juice, Clotrimazole, Triethanolamine, Methylparaben, Propylparaben
Antifungal Cream product label
INGREDIENTS AND APPEARANCE
| ANTIFUNGAL
undecylenic acid cream |
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| Labeler - Blaine Labs Inc. (017314571) |
| Registrant - Blaine Labs Inc. (017314571) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Blaine Labs Inc. | 017314571 | manufacture(63347-200) | |