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NDC 49348-0690-69 sunmark 3.5; 10000; 10 mg/g; [iU]/g; mg/g Details
sunmark 3.5; 10000; 10 mg/g; [iU]/g; mg/g
sunmark is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE.
Product Information
| NDC | 49348-0690 |
|---|---|
| Product ID | 49348-690_936c668e-6f45-421f-83e6-ea942ed0bc02 |
| Associated GPIs | 90109803353720 |
| GCN Sequence Number | 052110 |
| GCN Sequence Number Description | neomycin/polymyxin B/pramoxine CREAM (G) 3.5-10K-10 TOPICAL |
| HIC3 | Q5W |
| HIC3 Description | TOPICAL ANTIBIOTICS |
| GCN | 19626 |
| HICL Sequence Number | 025197 |
| HICL Sequence Number Description | NEOMYCIN SULFATE/POLYMYXIN B SULFATE/PRAMOXINE |
| Brand/Generic | Generic |
| Proprietary Name | sunmark |
| Proprietary Name Suffix | antibiotic plus pain relief |
| Non-Proprietary Name | Neomycin Sulfate, Polymyxin B Sulfate, and Pramoxine Hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 3.5; 10000; 10 |
| Active Ingredient Units | mg/g; [iU]/g; mg/g |
| Substance Name | NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE |
| Labeler Name | Strategic Sourcing Services LLC |
| Pharmaceutical Class | Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part333B |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49348-0690-69 (49348069069)
| NDC Package Code | 49348-690-69 |
|---|---|
| Billing NDC | 49348069069 |
| Package | 1 TUBE in 1 CARTON (49348-690-69) / 14.2 g in 1 TUBE |
| Marketing Start Date | 2013-02-13 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.18028 |
| Pricing Unit | GM |
| Effective Date | 2023-10-18 |
| NDC Description | SM ANTIBIOTIC PLUS CREAM |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
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 9b1d5d4a-136d-42fa-9f51-3093a05ca65e Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
For external use only
Do not use
- in the eyes
- over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week
Directions
Adults and children 2 years of age and older:
- clean the affected area and dry thoroughly
- apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
- may be covered with a sterile bandage
Children under 2 years of age: consult a doctor
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
INGREDIENTS AND APPEARANCE
| SUNMARK
ANTIBIOTIC PLUS PAIN RELIEF
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream |
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| Labeler - Strategic Sourcing Services LLC (116956644) |
| Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(49348-690) | |
Revised: 11/2019
Document Id: 936c668e-6f45-421f-83e6-ea942ed0bc02
Set id: 9b1d5d4a-136d-42fa-9f51-3093a05ca65e
Version: 2
Effective Time: 20191122