Tina Davies Icejelly Hemorrhoidal Cream
FDA Label NDC 84313-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tina Davies Professional Llc for the product Tina Davies Icejelly Hemorrhoidal (NDC 84313-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purposes, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Lidocaine 5% w/v
Phenylephrine HCl 0.25% w/v
Purposes
Local anesthetic
Vasoconstrictor
Uses
• for the temporary relief of:
• local itching and discomfort associated with hemorrhoids
• burning
• pain
• soreness
• temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.
• temporarily shrinks hemorrhoidal tissue.
Warnings
For external use only
Allergy alert: 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.
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.
• do not put this product into the rectum by using fingers or any mechanical device or applicator.
• in case of bleeding, consult a doctor promptly.
Stop use and ask a doctor if
• condition worsens or does not improve within 7 days.
• an allergic reaction develops.
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 Center right away.
Directions
• 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.
• apply externally to the affected area up to 4 times daily.
• children under 12 years of age: ask a doctor.
Other Information
• store at 20–25°C (68–77°F).
• protect from light.
• do not use if seal is broken or missing.
Inactive Ingredients
D&C Red No. 33, Disodium EDTA, Glycerin, Hydroxyethylcellulose, L-Cysteine HCl, Panthenol, Phenoxyethanol, Purified Water.
Questions Or Comments?
1-888-510-1388
You may also report serious side effects to this phone number.
Mon - Fri 9:00 AM - 5:00 PM
Packaging
Tina Davies Icejelly (84313101 2)
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