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NDC 63187-0543-01 Hydrocortisone 1 g/100g Details
Hydrocortisone 1 g/100g
Hydrocortisone is a TOPICAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 63187-0543-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 63187-0543 |
|---|---|
| Product ID | 63187-543_f8e2a7ad-bc62-438a-8824-2b8615d81c72 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Hydrocortisone |
| 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 | Proficient Rx LP |
| 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 63187-0543-01 (63187054301)
| NDC Package Code | 63187-543-01 |
|---|---|
| Billing NDC | 63187054301 |
| Package | 1 TUBE in 1 CARTON (63187-543-01) / 28.4 g in 1 TUBE |
| Marketing Start Date | 2018-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL c57d5f8e-5934-4cbb-999a-cdd55e5b105f 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
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- 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
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: do not use. consult a doctor
For external anal 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 application of this product
Children under 12 years of age: consult a doctor
Other information
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
INGREDIENTS AND APPEARANCE
| HYDROCORTISONE
hydrocortisone ointment |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(63187-543) , RELABEL(63187-543) | |
Revised: 1/2021
Document Id: f8e2a7ad-bc62-438a-8824-2b8615d81c72
Set id: c57d5f8e-5934-4cbb-999a-cdd55e5b105f
Version: 3
Effective Time: 20210101