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NDC 00904-6726-02 major prep hemorrhoidal 14; 74.9; .25 g/100g; g/100g; g/100g Details
major prep hemorrhoidal 14; 74.9; .25 g/100g; g/100g; g/100g
major prep hemorrhoidal is a RECTAL OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE.
Product Information
| NDC | 00904-6726 |
|---|---|
| Product ID | 0904-6726_11d2b2b0-85b5-4a66-9ddb-73944cb3591a |
| Associated GPIs | 89994003224222 |
| GCN Sequence Number | 071294 |
| GCN Sequence Number Description | phenyleph/mineral oil/petrolat OINT/APPL 0.25 %-14% RECTAL |
| HIC3 | Q3D |
| HIC3 Description | HEMORRHOIDAL PREPARATIONS |
| GCN | 35039 |
| HICL Sequence Number | 039599 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/MINERAL OIL/PETROLATUM,WHITE |
| Brand/Generic | Generic |
| Proprietary Name | major prep hemorrhoidal |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | mineral oil, petrolatum, phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | OINTMENT |
| Route | RECTAL |
| Active Ingredient Strength | 14; 74.9; .25 |
| Active Ingredient Units | g/100g; g/100g; g/100g |
| Substance Name | MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Major Pharmaceuticals |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part346 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00904-6726-02 (00904672602)
| NDC Package Code | 0904-6726-02 |
|---|---|
| Billing NDC | 00904672602 |
| Package | 1 TUBE in 1 CARTON (0904-6726-02) / 57 g in 1 TUBE |
| Marketing Start Date | 2018-09-06 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.04219 |
| Pricing Unit | GM |
| Effective Date | 2022-05-18 |
| NDC Description | MAJOR-PREP HEMORRHOIDAL OINT |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-06-29 |
This pricing file, entitled the NADAC (National Average Drug Acquisition
Cost) files, provide
state Medicaid agencies with covered outpatient drug prices by averaging
survey invoice
prices from retail community pharmacies across the United States. These
pharmacies include
independent retail community pharmacies and chain pharmacies. The prices
are updated on a
weekly and monthly basis
Standard Product Labeling (SPL)/Prescribing Information SPL 11d2b2b0-85b5-4a66-9ddb-73944cb3591a Details
Uses
- •
- helps relieve the local itching and discomfort associated with hemorrhoids
- •
- temporarily shrinks hemorrhoidal tissue and relieves burning
- •
- temporarily provides a coating for relief of anorectal discomforts
- •
- temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
Warnings
For external and/or intrarectal use only
Ask a doctor before use if you have
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- difficulty in urination due to enlargement of the prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression.
Keep out of reach of children.
Directions
- •
- adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment.
- •
- when first opening the tube, puncture foil seal with top end of cap
- •
- apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- •
- intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover
- •
- also apply ointment to external area
- •
- regular use provides continual therapy for relief of symptoms
- •
- children under 12 years of age: ask a doctor
Inactive ingredients
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| MAJOR PREP HEMORRHOIDAL
mineral oil, petrolatum, phenylephrine hcl ointment |
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| Labeler - Major Pharmaceuticals (191427277) |
Revised: 9/2018
Document Id: 11d2b2b0-85b5-4a66-9ddb-73944cb3591a
Set id: 11d2b2b0-85b5-4a66-9ddb-73944cb3591a
Version: 1
Effective Time: 20180910