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NDC 59779-0944-24 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 CVS Pharmacy. The primary component is GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE.
Product Information
| NDC | 59779-0944 |
|---|---|
| Product ID | 59779-944_a7883afc-7ebc-4dcd-b4b0-037f0e586692 |
| Associated GPIs | 89992004743720 |
| GCN Sequence Number | 061414 |
| GCN Sequence Number Description | phenyleph/pramoxin/glycr/w.pet CREAM (G) 0.25%-1% RECTAL |
| HIC3 | Q3D |
| HIC3 Description | HEMORRHOIDAL PREPARATIONS |
| GCN | 97205 |
| HICL Sequence Number | 034011 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/PRAMOXINE HCL/GLYCERIN/WHITE PETROLATUM |
| Brand/Generic | Generic |
| 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 | CVS Pharmacy |
| 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 59779-0944-24 (59779094424)
| NDC Package Code | 59779-944-24 |
|---|---|
| Billing NDC | 59779094424 |
| Package | 1 TUBE in 1 CARTON (59779-944-24) / 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 3167c918-a7d3-46a1-a85b-64f9c22916f2 Details
Uses
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- for temporary relief of pain, soreness and burning
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- 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.
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- 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
Compare to the active ingredients in Preparation H® Cream
Hemorrhoidal Cream
SMOOTH CREAM FORMULA with ALOE
Rapid, soothing pain relief from painful burning, itching & discomfort
Protects irritated tissue
Relieves external discomfort
Shrinks swollen hemorrhoidal tissue
with Aloe
Package Contains One Tube
NET WT 1.8 OZ (51 g)
INGREDIENTS AND APPEARANCE
| HEMORRHOIDAL
glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream |
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| Labeler - CVS Pharmacy (062312574) |
Revised: 1/2020
Document Id: a7883afc-7ebc-4dcd-b4b0-037f0e586692
Set id: 3167c918-a7d3-46a1-a85b-64f9c22916f2
Version: 24
Effective Time: 20200102