FDA Label for Treatonic Hemorrhoid Treatment
View Indications, Usage & Precautions
Treatonic Hemorrhoid Treatment Product Label
The following document was submitted to the FDA by the labeler of this product 100 Karma 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.
Otc - Active Ingredient
- Lidocaine 5%
- Phenylephrine HCI 0.25%
Otc - Purpose
- Topical anesthetic
- Vasoconstrictor
Dosage & Administration
- For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.
- For the temporary reliefofpain, burning and soreness.
- Temporarily shrinks hemorrhoidal tissue.
- Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.
Warnings
For external and / or intrarectal use only.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
Otc - Do Not Use
- Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
- Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain.
- Consult a doctor promptly.
Otc - Stop Use
- lf the condition worsens or does not improve within 7 days, consult a doctor.
- 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 symptombeing treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children, if swallowed, get medical help or contact poison control center right away.
Indications & Usage
- Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.
- For External use: Apply externally to the affected area up to 4 times daily.
- For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Apply to the affected area up to 4 times daily.
Other Safety Information
- Keep away from direct sunlight or heat.
- Store at room temperature 15°-30°C(59°-86°F).
- This package is child-resistant. Keep out of reach of children.
- In case of accidental overdose or ingestion, call a doctor or poison control center immediately.
Inactive Ingredient
Water, Ethylhexyl Palmitate, Zinc Oxide, Glycerin, Propylene Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Glyceryl Stearate, Gentiana Scabra Root Extract, Centella Asiatica Extract, Menthol, PEG-100 Stearate, Carbomer, Allantoin, Salvia Miltiorrhiza Root Extract, Angelica Polymorpha Sinensis Root Extract, Eugenia Caryophyllus (Clove) Bud Extract, Glycyrrhiza Uralensis (Licorice) Root
Extract, Dendrobium Officinale Stem Extract, Stephania Tetrandra Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Taxus Cuspidata Leaf Extract, Smilax Glabra Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Potassium Alum, Caprylhydroxamic Acid, Phenoxyethanol.
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