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NDC 51862-0180-15 Pramoxine hydrochloride 10 mg/g Details
Pramoxine hydrochloride 10 mg/g
Pramoxine hydrochloride is a TOPICAL AEROSOL, FOAM in the HUMAN OTC DRUG category. It is labeled and distributed by Mayne Pharma. The primary component is PRAMOXINE HYDROCHLORIDE.
MedlinePlus Drug Summary
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: 51862-0180-15Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Pramoxine
Product Information
| NDC | 51862-0180 |
|---|---|
| Product ID | 51862-180_920da7e2-796f-41c2-a6dc-f01a90537d90 |
| Associated GPIs | 89200030103905 |
| GCN Sequence Number | 062043 |
| GCN Sequence Number Description | pramoxine HCl FOAM 1 % TOPICAL |
| HIC3 | Q3D |
| HIC3 Description | HEMORRHOIDAL PREPARATIONS |
| GCN | 97827 |
| HICL Sequence Number | 002977 |
| HICL Sequence Number Description | PRAMOXINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Pramoxine hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Pramoxine hydrochloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | AEROSOL, FOAM |
| Route | TOPICAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/g |
| Substance Name | PRAMOXINE HYDROCHLORIDE |
| Labeler Name | Mayne Pharma |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 51862-0180-15 (51862018015)
| NDC Package Code | 51862-180-15 |
|---|---|
| Billing NDC | 51862018015 |
| Package | 1 CONTAINER in 1 CARTON (51862-180-15) / 15 g in 1 CONTAINER |
| Marketing Start Date | 2011-10-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 54a5e0e3-a400-4cc8-87eb-bcab8309786d Details
INACTIVE INGREDIENTS:
DIRECTIONS: SHAKE WELL BEFORE USE.
WARNINGS:
Do not exceed the recommended daily dosage unless directed by a physician. If condition worsens or does not improve within 7 days, consult a physician. In case of rectal bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use immediately and consult a physician. Do not use in the eyes or nose. Do not apply to large areas of the body.
CAUTION: FOR EXTERNAL USE ONLY.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 15 g Container Carton
INGREDIENTS AND APPEARANCE
| PRAMOXINE HYDROCHLORIDE
pramoxine hydrochloride aerosol, foam |
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| Labeler - Mayne Pharma (867220261) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sciarra Laboratories, Inc. | 824900369 | MANUFACTURE(51862-180) , PACK(51862-180) , LABEL(51862-180) | |