FDA Label for Signature Care Hemorrhoidal
View Indications, Usage & Precautions
Signature Care Hemorrhoidal Product Label
The following document was submitted to the FDA by the labeler of this product Better Living Brands, 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.
Otc - Active Ingredient
Active ingredients Purpose
Mineral oil 14%..............................................Protectant
Petrolatum 74.9%..........................................Protectant
Phenylephrine HCI 0.25%..........................Vasconstrictor
Otc - Purpose
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 bowel movements less painful
Warnings
Warnings
For external and/or intrarectal use only
Otc - Ask Doctor
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 of pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
Otc - When Using
When using this product do not exceed the recommended daily dosage unless directed by a doctor.
Otc - Stop Use
Stop use and ask a doctor if
- bleeding occurs
- condition worsens or does not improve within 7 days
- introduction of applicator into rectum causes additional pain
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control right away.
Indications & Usage
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
- interacetal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into 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
Storage And Handling
Other information
- store at 20-25°C (68-77°F)
- Lot No. & Exp. Date: see box or see crimp of tube
Inactive Ingredient
Inactive ingredients
ethanol, glycerin, lanolin, methylparaben, polysorbate 80, propylparaben, stearyl alcohol, thyme oil, tocopherol acetate, water, white wax
Dosage & Administration
Distributed by:
Better Living Brands LLC
P.O. Box 99
Pleasanton, CA 94566-0009
1-888-723-3929
Made in Korea
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