Drugplain

topcare hemorrhoidal 14.4 g/100g

glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum · CREAM · Topco Associates LLC

No Recall History
Plain English

topcare hemorrhoidal is a cream containing glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum at 14.4 g/100g, taken topical. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
topcare hemorrhoidal
Generic Name
glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum
NDC Code (Product)
36800-944
Manufacturer
Topco Associates LLC
Strength
14.4 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M015
Drug Class
Non-Standardized Chemical Allergen [EPC]
Marketing Start
11/03/2011

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

abdominal discomfort1 reports
abdominal pain upper1 reports
adjustment disorder with depressed mood1 reports
alopecia1 reports
amnesia1 reports
anti-cyclic citrullinated peptide antibody positive1 reports
arthralgia1 reports
arthropathy1 reports
back disorder1 reports
blister1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

Warnings

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 Stop use and ask a doctor if • bleeding occurs • condition worsens or does not improve within 7 days • an allergic reaction develops • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is topcare hemorrhoidal used for?

topcare hemorrhoidal contains glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum. It is a cream taken topical. Consult your doctor for specific uses.

Is topcare hemorrhoidal a controlled substance?

topcare hemorrhoidal is not classified as a controlled substance by the DEA.

What is the generic name for topcare hemorrhoidal?

The generic name for topcare hemorrhoidal is glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum. There are 11 other brand versions of glycerin, phenylephrine HCl, pramoxine HCl, white petrolatum.

What is the NDC code for topcare hemorrhoidal 14.4 g/100g?

The NDC (National Drug Code) for topcare hemorrhoidal 14.4 g/100g is 36800-944, listed by Topco Associates LLC.