FDA Label for Mineral Oil, Petrolatum And Phenylephrine Hcl
View Indications, Usage & Precautions
- ACTIVE INGREDIENTS
- PURPOSES
- USES
- WARNINGS
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL - 56.8 G TUBE CARTON
Mineral Oil, Petrolatum And Phenylephrine Hcl Product Label
The following document was submitted to the FDA by the labeler of this product Axcentria Pharmaceuticals, Llc. 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 71.9%
Phenylephrine HCl 0.25%
Purposes
Protectant
Protectant
Vasoconstrictor
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 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.
Stop Use And Ask A Doctor If
- bleeding occurs
- condition worsens or does not improve within 7 days
- introduction of applicator into the rectum causes additional pain
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.
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, puncture foil seal with top end of cap
- apply to the affected area up to 4 times daily, especially at night, 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
- children under 12 years of age: ask a doctor
Other Information
store at 20-25°C (68-77°F)
Inactive Ingredients
benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, shark liver oil, thymus vulgaris (thyme) flower/leaf oil, tocopherols excipient, white wax
Questions?
To report adverse drug event call: (800) 616-2417
Principal Display Panel - 56.8 G Tube Carton
HEMORRHOIDAL
OINTMENT
TAMPER-EVIDENT: Do not use if printed "safety sealed" overwrap is broken or missing.
- Prompt, Soothing Relief from painful burning, itching and discomfort
- Shrinks swollen hemorrhoidal tissue
- Protects irritated tissue
- Relieves internal and external discomfort
NET WT 2 OZ (56.8 g)
* Please review the disclaimer below.