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NDC 45802-0050-03 dibucaine 1 g/100g Details
dibucaine 1 g/100g
dibucaine is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is DIBUCAINE.
Product Information
| NDC | 45802-0050 |
|---|---|
| Product ID | 45802-050_d3df1be8-40f1-4ee7-8abc-649e9aeeee9a |
| Associated GPIs | 89200017004210 |
| GCN Sequence Number | 007484 |
| GCN Sequence Number Description | dibucaine OINT. (G) 1 % TOPICAL |
| HIC3 | Q5H |
| HIC3 Description | TOPICAL LOCAL ANESTHETICS |
| GCN | 30730 |
| HICL Sequence Number | 002979 |
| HICL Sequence Number Description | DIBUCAINE |
| Brand/Generic | Generic |
| Proprietary Name | dibucaine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | dibucaine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | OINTMENT |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/100g |
| Substance Name | DIBUCAINE |
| Labeler Name | Padagis Israel Pharmaceuticals Ltd |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 45802-0050-03 (45802005003)
| NDC Package Code | 45802-050-03 |
|---|---|
| Billing NDC | 45802005003 |
| Package | 1 TUBE in 1 CARTON (45802-050-03) / 28 g in 1 TUBE |
| Marketing Start Date | 2011-06-20 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.14923 |
| Pricing Unit | GM |
| Effective Date | 2022-10-19 |
| NDC Description | DIBUCAINE 1% OINTMENT |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 005f54e3-f60a-4c26-b830-b5127786e5bd Details
Uses
Warnings
For external use only
Allergy warning: Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and ask a doctor.
When using this product
for hemorrhoidal:
- •
- do not exceed the recommended daily dosage unless directed by a doctor
- •
- do not put this product into the rectum by using fingers or any mechanical device or applicator
for topical analgesic:
- •
- do not use in large quantities, particularly over raw surfaces or blistered areas
Directions
for hemorrhoidal:
- •
- adults and children 12 years & older: when practical, clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
- •
- apply externally to the affected area up to 3 or 4 times daily
- •
- children under 12 years of age: ask a doctor
for topical analgesic:
- •
- adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
- •
- children under 2 years of age: ask a doctor
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| DIBUCAINE
dibucaine ointment |
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| Labeler - Padagis Israel Pharmaceuticals Ltd (600093611) |
Revised: 11/2021
Document Id: d3df1be8-40f1-4ee7-8abc-649e9aeeee9a
Set id: 005f54e3-f60a-4c26-b830-b5127786e5bd
Version: 4
Effective Time: 20211110