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NDC 36800-0944-24 topcare hemorrhoidal 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g Details
topcare hemorrhoidal 14.4; 15; .25; 1 g/100g; g/100g; g/100g; g/100g
topcare hemorrhoidal is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE.
Product Information
| NDC | 36800-0944 |
|---|---|
| Product ID | 36800-944_3aaad9ad-9fce-4f68-9cee-41c999faba57 |
| 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 | topcare 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 | Topco Associates LLC |
| 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 36800-0944-24 (36800094424)
| NDC Package Code | 36800-944-24 |
|---|---|
| Billing NDC | 36800094424 |
| Package | 1 TUBE in 1 CARTON (36800-944-24) / 51 g in 1 TUBE |
| Marketing Start Date | 2011-11-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5e13da07-48cf-40bc-bb11-fd891886cbea 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
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- 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
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- 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
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- 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
TopCare® health
COMPARE TO PREPARATION H® CREAM ACTIVE INGREDIENTS
MAXIMUM STRENGTH PAIN RELIEF
Hemorrhoidal Cream
SMOOTH CREAM FORMULA WITH ALOE
• Rapid Soothing Pain Relief from Painful Burning, Itching and Discomfort
• Shrinks Swollen Hemorrhoidal Tissue • Protects Irritated Tissue • Relieves External Discomfort
NET WT 1.8 OZ (51g)
INGREDIENTS AND APPEARANCE
| TOPCARE HEMORRHOIDAL
glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum cream |
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| Labeler - Topco Associates LLC (006935977) |
Revised: 2/2022
Document Id: 3aaad9ad-9fce-4f68-9cee-41c999faba57
Set id: 5e13da07-48cf-40bc-bb11-fd891886cbea
Version: 3
Effective Time: 20220221