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NDC 45802-0438-03 hydrocortisone 1 g/100g Details
hydrocortisone 1 g/100g
hydrocortisone is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. 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: 45802-0438-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 45802-0438 |
|---|---|
| Product ID | 45802-438_9ac2242d-ac10-45ea-86d6-0ded80dfd988 |
| Associated GPIs | 90550075003720 |
| GCN Sequence Number | 007544 |
| GCN Sequence Number Description | hydrocortisone CREAM (G) 1 % TOPICAL |
| HIC3 | Q5P |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
| GCN | 30942 |
| HICL Sequence Number | 002867 |
| HICL Sequence Number Description | HYDROCORTISONE |
| Brand/Generic | Generic |
| Proprietary Name | hydrocortisone |
| Proprietary Name Suffix | n/a |
| 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 | Padagis Israel Pharmaceuticals Ltd |
| 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 45802-0438-03 (45802043803)
| NDC Package Code | 45802-438-03 |
|---|---|
| Billing NDC | 45802043803 |
| Package | 1 TUBE in 1 CARTON (45802-438-03) / 28 g in 1 TUBE |
| Marketing Start Date | 2011-05-06 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.06188 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | HYDROCORTISONE 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 2dc7f76f-f9ad-46ba-8b41-952e1c15f052 Details
Uses
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- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
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- eczema
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- insect bites
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- poison ivy, oak, or sumac
- •
- soaps
- •
- detergents
- •
- cosmetics
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- jewelry
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- seborrheic dermatitis
- •
- psoriasis
- •
- temporarily relieves external anal and genital itching
- •
- other uses of this product should only be under the advice and supervision of a doctor
Warnings
For external use only
Do not use
- •
- in the genital area if you have a vaginal discharge. Consult a doctor.
- •
- for the treatment of diaper rash. Consult a doctor.
When using this product
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- avoid contact with eyes
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- do not use more than directed unless told to do so by a doctor
- •
- do not put directly into the rectum by using fingers or any mechanical device or applicator
Directions
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- for itching of skin irritation, inflammation, and rashes:
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- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
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- children under 2 years of age: ask a doctor
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- for external anal and genital itching, adults:
- •
- 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 applying
- •
- apply to affected area not more than 3 to 4 times daily
- •
- children under 12 years of age: ask a doctor
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| HYDROCORTISONE
hydrocortisone cream |
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| Labeler - Padagis Israel Pharmaceuticals Ltd (600093611) |
Revised: 11/2021
Document Id: 9ac2242d-ac10-45ea-86d6-0ded80dfd988
Set id: 2dc7f76f-f9ad-46ba-8b41-952e1c15f052
Version: 6
Effective Time: 20211110