FDA Label for Careall Hemorrhoidal
View Indications, Usage & Precautions
Careall Hemorrhoidal Product Label
The following document was submitted to the FDA by the labeler of this product New World Imports, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
* Please review the disclaimer below.