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NDC 47682-0211-35 Hydrocortisone 10 mg/g Details
Hydrocortisone 10 mg/g
Hydrocortisone is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Unifirst First Aid Corporation. 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: 47682-0211-35Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 47682-0211 |
|---|---|
| Product ID | 47682-211_ec190869-82bc-6c7f-e053-2a95a90a8577 |
| Associated GPIs | 90550075103720 |
| 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 | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/g |
| Substance Name | HYDROCORTISONE |
| Labeler Name | Unifirst First Aid Corporation |
| 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 47682-0211-35 (47682021135)
| NDC Package Code | 47682-211-35 |
|---|---|
| Billing NDC | 47682021135 |
| Package | 144 POUCH in 1 BOX (47682-211-35) / .9 g in 1 POUCH (47682-211-99) |
| Marketing Start Date | 2013-04-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL e90df2e5-2ef4-47dd-bd74-be9cea6d9d85 Details
SPL UNCLASSIFIED SECTION
Uses
- for the temporary relief of itching associated with minor skin irritations, inflamation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes
- other uses of this product should be only under the advice and supervision of a doctor
SPL UNCLASSIFIED SECTION
Warnings
For external use only
Do not use
- for the treatment of diaper rash
- with anyother Hydrocortisone product unless you have consulted adoctor
- if you have vaginal discharge, consulkt a doctor
SPL UNCLASSIFIED SECTION
Directions
- for adults and children (2 years of age and older): apply to affected area 3 to 4 times daily
- children under 12 years of age: for external anal itching, consult a doctor
- children under 2 years of age: do not use, consult a doctor
- adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
- gently dry by patting or botting with toilet tissue or a soft cloth before application of this product
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Medi-First Hydrocortisone Label
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| HYDROCORTISONE
hydrocortisone cream |
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| Labeler - Unifirst First Aid Corporation (832947092) |
Revised: 10/2022
Document Id: ec190869-82bc-6c7f-e053-2a95a90a8577
Set id: e90df2e5-2ef4-47dd-bd74-be9cea6d9d85
Version: 16
Effective Time: 20221028