Search by Drug Name or NDC
NDC 54766-0726-06 Pramosone 25; 10 mg/mL; mg/mL Details
Pramosone 25; 10 mg/mL; mg/mL
Pramosone is a TOPICAL LOTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sebela Pharmaceuticals Inc.. The primary component is HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE.
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: 54766-0726-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Hydrocortisone Topical
Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.
Related Packages: 54766-0726-06Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine
Product Information
| NDC | 54766-0726 |
|---|---|
| Product ID | 54766-726_0bd81067-6752-4959-e063-6394a90acd00 |
| Associated GPIs | 90559802404125 |
| GCN Sequence Number | 007418 |
| GCN Sequence Number Description | hydrocortisone/pramoxine LOTION 2.5 %-1 % TOPICAL |
| HIC3 | T0F |
| HIC3 Description | TOPICAL ANTI-INFLAMMATORY STEROID-LOCAL ANESTHETIC |
| GCN | 84641 |
| HICL Sequence Number | 015163 |
| HICL Sequence Number Description | HYDROCORTISONE ACETATE/PRAMOXINE HCL |
| Brand/Generic | Brand |
| Proprietary Name | Pramosone |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | hydrocortisone acetate and pramoxine hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 25; 10 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE |
| Labeler Name | Sebela Pharmaceuticals Inc. |
| Pharmaceutical Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA085979 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 54766-0726-06 (54766072606)
| NDC Package Code | 54766-726-06 |
|---|---|
| Billing NDC | 54766072606 |
| Package | 59 mL in 1 BOTTLE, PLASTIC (54766-726-06) |
| Marketing Start Date | 2015-08-07 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |