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NDC 49348-0522-72 sunmark 1 g/100g Details
sunmark 1 g/100g
sunmark is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is HYDROCORTISONE.
MedlinePlus Drug Summary
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.
Related Packages: 49348-0522-72Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 49348-0522 |
|---|---|
| Product ID | 49348-522_0490487f-9bb5-49ca-8db2-4495211f639d |
| Associated GPIs | 90550075004210 |
| GCN Sequence Number | 007547 |
| GCN Sequence Number Description | hydrocortisone OINT. (G) 1 % TOPICAL |
| HIC3 | Q5P |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
| GCN | 30951 |
| HICL Sequence Number | 002867 |
| HICL Sequence Number Description | HYDROCORTISONE |
| Brand/Generic | Generic |
| Proprietary Name | sunmark |
| Proprietary Name Suffix | Hydrocortisone |
| Non-Proprietary Name | Hydrocortisone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | OINTMENT |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/100g |
| Substance Name | HYDROCORTISONE |
| Labeler Name | Strategic Sourcing Services LLC |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part348 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 49348-0522-72 (49348052272)
| NDC Package Code | 49348-522-72 |
|---|---|
| Billing NDC | 49348052272 |
| Package | 1 TUBE in 1 CARTON (49348-522-72) / 28.4 g in 1 TUBE |
| Marketing Start Date | 2013-02-13 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.07441 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | SM HYDROCORTISONE 1% OINTMENT |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 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 210079e9-3d2f-4489-b468-b96b145034ed Details
Uses
for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
- eczema
- seborrheic dermatitis
- psoriasis
- insect bites
- poison ivy, oak, sumac
- soaps
- detergents
- cosmetics
- jewelry
- external genital and anal itching
other uses of this product should be only under the advice and supervision of a doctor.
Warnings
- for external use only
- avoid contact with the eyes
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop using this product and ask a doctor
- in case of bleeding
- if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
- before you begin using any other hydrocortisone product
Do not use this product and ask a doctor
- if you have a vaginal discharge
- before treating diaper rash
- before using on children under 2 years of age
Directions
- when practical, cleanse 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 application of this product
- adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
- children under 12 years of age: Do not use, consult a doctor
Other information
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
INGREDIENTS AND APPEARANCE
| SUNMARK
HYDROCORTISONE
hydrocortisone ointment |
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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(49348-522) | |
Revised: 11/2019
Document Id: 0490487f-9bb5-49ca-8db2-4495211f639d
Set id: 210079e9-3d2f-4489-b468-b96b145034ed
Version: 2
Effective Time: 20191125