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NDC 41250-0944-24 hemorrhoidal 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g Details
hemorrhoidal 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g
hemorrhoidal is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Meijer Distribution Inc. The primary component is GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE.
Product Information
| NDC | 41250-0944 |
|---|---|
| Product ID | 41250-944_f3a5c401-3131-44ba-a78c-ddfa5bb57495 |
| Associated GPIs | |
| 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 | hemorrhoidal |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 14.4; 15; .25; 1 |
| Active Ingredient Units | g/100g; g/100g; g/100g; g/100g |
| Substance Name | GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE |
| Labeler Name | Meijer Distribution Inc |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], 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 41250-0944-24 (41250094424)
| NDC Package Code | 41250-944-24 |
|---|---|
| Billing NDC | 41250094424 |
| Package | 1 TUBE in 1 CARTON (41250-944-24) / 51 g in 1 TUBE |
| Marketing Start Date | 2008-02-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL fb170371-2e5d-43ca-a259-538a973ee3b8 Details
Uses
- •
- for temporary relief of pain, soreness and burning
- •
- helps relieve the local itching and discomfort associated with hemorrhoids
- •
- temporarily shrinks hemorrhoidal tissue
- •
- 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 use only
Ask a doctor before use if you have
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
Ask a doctor or pharmacist before use if you are
presently taking a prescription drug for high blood pressure or depression
When using this product
- •
- do not exceed the recommended daily dosage unless directed by a doctor
- •
- do not put into the rectum by using fingers or any mechanical device or applicator
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 cream.
- •
- when first opening the tube, puncture foil seal with top end of cap
- •
- apply externally or in the lower portion of the anal canal only
- •
- apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
- •
- for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.
- •
- thoroughly cleanse dispensing cap after each use and replace cover
- •
- children under 12 years of age: ask a doctor
Inactive ingredients
aloe barbadensis leaf extract, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid, edetate disodium, glyceryl monostearate, laureth-23, methylparaben, mineral oil, panthenol, propyl gallate, propylparaben, purified water, sodium benzoate, steareth-2, steareth-20, stearyl alcohol, vitamin E, xanthan gum
Principal Display Panel
INGREDIENTS AND APPEARANCE
| HEMORRHOIDAL
glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream |
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| Labeler - Meijer Distribution Inc (006959555) |
Revised: 3/2019
Document Id: f3a5c401-3131-44ba-a78c-ddfa5bb57495
Set id: fb170371-2e5d-43ca-a259-538a973ee3b8
Version: 3
Effective Time: 20190314