Careall Hemorrhoidal Ointment
FDA Label NDC 51824-079

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Hemorrhoidal (NDC 51824-079). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Purpose

Active Ingredients Purposes
Mineral Oil 14%...................................................................Protectant
Petrolatum 74.9%................................................................Protectant
Phenylephrine HCl 0.25%...............................................Vasoconstrictor

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

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 useif 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
Stop use and ask a doctor if
▪ bleeding occurs ▪ condition worsens or does not improved within 7 days
▪ introduction of applicator into the rectum causes additional pain
If pregnant or breast-feeding, ask a health professional before use.

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, peel off soil seal and attach applicator
 apply to the affected area up to 4 times daily, especially at night and 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

Benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thymus vulgaris (thyme) leaf oil, tocopherol, white wax

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