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NDC 00536-1277-80 RUGBY HYDROCORTISONE WITH ALOE 0.01 g/g Details
RUGBY HYDROCORTISONE WITH ALOE 0.01 g/g
RUGBY HYDROCORTISONE WITH ALOE is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by RUGBY. 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: 00536-1277-80Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 00536-1277 |
|---|---|
| Product ID | 0536-1277_8f428539-3797-4a6a-8a11-d6f26a2019dc |
| Associated GPIs | 90559902503720 |
| GCN Sequence Number | 016266 |
| GCN Sequence Number Description | hydrocortisone/aloe vera CREAM (G) 1 % TOPICAL |
| HIC3 | Q5P |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
| GCN | 92421 |
| HICL Sequence Number | 003289 |
| HICL Sequence Number Description | HYDROCORTISONE/ALOE VERA |
| Brand/Generic | Generic |
| Proprietary Name | RUGBY HYDROCORTISONE WITH ALOE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | HYDROCORTISONE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 0.01 |
| Active Ingredient Units | g/g |
| Substance Name | HYDROCORTISONE |
| Labeler Name | RUGBY |
| 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 00536-1277-80 (00536127780)
| NDC Package Code | 0536-1277-80 |
|---|---|
| Billing NDC | 00536127780 |
| Package | 1 TUBE in 1 CARTON (0536-1277-80) / 28 g in 1 TUBE |
| Marketing Start Date | 2020-01-14 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.05643 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | HYDROCORTISONE-ALOE 1% CREAM |
| 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 796e792b-20c4-4a43-b7a2-55d31ee04092 Details
Uses
Warnings
For external use only.
Avoid contact with eyes.
When using this product
- do not exceed the recommended daily dosage unless directed by a doctor
- do not put into the rectum by using fingers or any mechanical device or applicator
Directions
For itching associated with minor skin irritations, inflammation, and rashes:
Adults and children 2 years of age and older:
- apply to affected area not more than 3 to 4 times daily
Children under 2 years of age: Consult a doctor
For external anal and genital itching:
Adults and children 12 years of age and older:
- when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
- gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
- apply to affected area not more than 3 to 4 times daily
Children under 12 years of age: Consult a doctor
Other information
Inactive ingredients
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
INGREDIENTS AND APPEARANCE
| RUGBY HYDROCORTISONE WITH ALOE
hydrocortisone cream |
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| Labeler - RUGBY (079246066) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Natureplex LLC | 062808196 | MANUFACTURE(0536-1277) | |
Revised: 1/2020
Document Id: 8f428539-3797-4a6a-8a11-d6f26a2019dc
Set id: 796e792b-20c4-4a43-b7a2-55d31ee04092
Version: 2
Effective Time: 20200121