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NDC 50090-5856-00 Hydrocortisone Maximum Strength 1 g/100g Details
Hydrocortisone Maximum Strength 1 g/100g
Hydrocortisone Maximum Strength is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by A-S Medication Solutions. 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: 50090-5856-00Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 50090-5856 |
|---|---|
| Product ID | 50090-5856_f8a61cba-c763-42b2-a349-3d9ec95c1e21 |
| 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 | Hydrocortisone Maximum Strength |
| Proprietary Name Suffix | n/a |
| 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 | A-S Medication Solutions |
| 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 50090-5856-00 (50090585600)
| NDC Package Code | 50090-5856-0 |
|---|---|
| Billing NDC | 50090585600 |
| Package | 1 TUBE in 1 CARTON (50090-5856-0) / 28 g in 1 TUBE |
| Marketing Start Date | 2021-11-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 66cf83dd-4205-4ae7-a7d4-7e0e1aebaadf Details
Uses
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to
- eczema
- psoriasis
- insect bites
- poison ivy, oak, sumac
- detergents
- jewelry
- cosmetics
- soaps
- seborrheic dermatitis
- temporarily relieves external anal and genital 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 genital area if you have a vaginal discharge. Consult a doctor.
- for the treatment of diaper rash. Consult a doctor.
When using this product
- avoid contact with the eyes
- do not use more than directed unless directed by a doctor
- do not put directly into the rectum by using fingers or any mechanical device or applicator
Directions
- for itching of skin irritation, 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: when practical, clean the affected area with mild soap and warm water; rinse thoroughly
- 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
INGREDIENTS AND APPEARANCE
| HYDROCORTISONE MAXIMUM STRENGTH
hydrocortisone ointment |
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| Labeler - A-S Medication Solutions (830016429) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| A-S Medication Solutions | 830016429 | RELABEL(50090-5856) | |
Revised: 6/2022
Document Id: f8a61cba-c763-42b2-a349-3d9ec95c1e21
Set id: 66cf83dd-4205-4ae7-a7d4-7e0e1aebaadf
Version: 3
Effective Time: 20220621