FDA Label for Hemorrhoid Anesthetic
View Indications, Usage & Precautions
Hemorrhoid Anesthetic Product Label
The following document was submitted to the FDA by the labeler of this product Anicare Pharmaceuticals Pvt. Ltd. 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
Mineral Oil 14%
Petrolatum 74.9%
Phenylephrine HCL 0.25%
Otc - Purpose
Purpose
Protectant
Protectant
Vasoconstrictor
Indications & Usage
Uses
- For the temporary relief of local anorectal burning and discomfort associated with hemmorrhoids, anorectal disorders, inflamed hemorrhoidal tissues or piles.
Warnings
Warnings
For external use only.
Otc - Stop Use
- Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clean-up and occur again within a few days.
- Do not exceed the recommended daily dosage unless directed by a doctor.
- In case of bleeding, consult a doctor promptly.
- Certain persons can develop allergic reactions to ingredients in this product.
- If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.
- If you are pregnant, do not use this product without first consulting a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If ingested seek medical attention immediately or contact a Poison Control Center right away.
Dosage & Administration
Directions
- Cleanse the affected area with mild soap and warm water, rinse thoroughly.
- Dry by patting or blotting with toilet tissue or soft cloth before applying this product.
- Cover the entire affected area with a thin layer 1 to 3 times daily.
- Children under 12 years of age need to consult a doctor before using this product.
Other
Other Information
- Store at 20°C to 25°C (68°F to 77°F)
- Lot No. & Exp. Date: see crimp of tube.
Inactive Ingredient
Inactive Ingredients
benzoic acid, butylated hydroxyanisole, glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, tocopherol acetate, yellow wax.
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL
Hemorrhoid Anesthetic Ointment
NET WT. 1 OZ. (28 g)
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