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NDC 72189-0276-28 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 DIRECT RX. 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: 72189-0276-28Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Product Information
| NDC | 72189-0276 |
|---|---|
| Product ID | 72189-276_cc82086b-3035-1805-e053-2a95a90af0bd |
| Associated GPIs | 90550075103720 |
| GCN Sequence Number | 015189 |
| GCN Sequence Number Description | hydrocortisone acetate CREAM (G) 1 % TOPICAL |
| HIC3 | Q5P |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROIDAL |
| GCN | 30841 |
| HICL Sequence Number | 002863 |
| HICL Sequence Number Description | HYDROCORTISONE ACETATE |
| 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 | 10 |
| Active Ingredient Units | mg/g |
| Substance Name | HYDROCORTISONE |
| Labeler Name | DIRECT RX |
| 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 72189-0276-28 (72189027628)
| NDC Package Code | 72189-276-28 |
|---|---|
| Billing NDC | 72189027628 |
| Package | 28.4 g in 1 TUBE (72189-276-28) |
| Marketing Start Date | 2021-09-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL cc82086b-3034-1805-e053-2a95a90af0bd Details
SPL UNCLASSIFIED SECTION
Relieves itches and rashes due to:
Eczema
Psoriasis
Seborrheic dermatitis
Poison ivy
Poison oak
Poison sumac
Insect bites
External anal itching
Soaps
Detergents
Cosmetics
Jewelry
Temporary relief of external anal and genital itching.
Other use of the product should only be under the advice and supervision of a doctor.
SPL UNCLASSIFIED SECTION
For external use only
Do not use:
In the eyes
For diaper rash
If you have vaginal discharge
More than the recommended dosage
Ask doctor before use:
If you are pregnant or breast feeding
Stop use and ask a doctor if:
Condition worsens, or is symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor.
When using this product:
Do not put this product into rectum by using fingers or any mechanical device or applicator.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Adults and children over 2 years of age - Apply to affected area not more than 3-4 times per day.
Children under 2 years of age - Do not use. Consult a doctor.
For external anal itching Adults - When practical cleanse the affcted area with mild soap and water and rinse thoroughly. Gently dry patting with bathroom tissue or soft cloth before applying. Apply to affected area not more than 3-4 times per day. Children under 12 years of age: consult a doctor.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| HYDROCORTISONE
hydrocortisone cream |
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| Labeler - DIRECT RX (079254320) |
| Registrant - DIRECT RX (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DIRECT RX | 079254320 | relabel(72189-276) | |