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NDC 41415-0048-75 Publix 1 g/100g Details
Publix 1 g/100g
Publix is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Publix Super Markets Inc. 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: 41415-0048-75Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 41415-0048 |
|---|---|
| Product ID | 41415-048_946dff34-1693-48f9-a771-e8c1f0888dbb |
| Associated GPIs | 48300010000510 |
| GCN Sequence Number | 002689 |
| GCN Sequence Number Description | calcium carbonate TAB CHEW 200(500)MG ORAL |
| HIC3 | D4B |
| HIC3 Description | ANTACIDS |
| GCN | 07893 |
| HICL Sequence Number | 001163 |
| HICL Sequence Number Description | CALCIUM CARBONATE |
| Brand/Generic | Generic |
| Proprietary Name | Publix |
| Proprietary Name Suffix | hydro plus |
| Non-Proprietary Name | Hydrocortisone |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 1 |
| Active Ingredient Units | g/100g |
| Substance Name | HYDROCORTISONE |
| Labeler Name | Publix Super Markets Inc |
| 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 | 2023-12-31 |
Package
Package Images
NDC 41415-0048-75 (41415004875)
| NDC Package Code | 41415-048-75 |
|---|---|
| Billing NDC | 41415004875 |
| Package | 1 TUBE in 1 CARTON (41415-048-75) / 28.4 g in 1 TUBE |
| Marketing Start Date | 1989-10-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a00d82c1-6b09-424a-be78-2603eee3fb9d Details
Uses
- temporary relief of itching associated with minor skin irritations and rashes due to
- eczema
- insect bites
- poison ivy, poison oak, or poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- 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
Do not use
- in the eyes
- by putting this product into the rectum by using fingers or any mechanical device or applicator
Directions
Other information
Inactive ingredients
aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
INGREDIENTS AND APPEARANCE
| PUBLIX
HYDRO PLUS
hydrocortisone cream |
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| Labeler - Publix Super Markets Inc (006922009) |
| Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Taro Pharmaceuticals Inc. | 206263295 | MANUFACTURE(41415-048) | |
Revised: 12/2021
Document Id: 946dff34-1693-48f9-a771-e8c1f0888dbb
Set id: a00d82c1-6b09-424a-be78-2603eee3fb9d
Version: 2
Effective Time: 20211215