Tina Davies Icecream Hemorrhoidal Cream
FDA Label NDC 84313-002

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 Icecream Hemorrhoidal (NDC 84313-002). 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

Drug Facts

Active Ingredients

Lidocaine 5% w/v
Phenylephrine HCl 0.25% w/v

Purposes

Local anesthetic
Vasoconstrictor

Uses

  • for the temporary relief of anorectal itching and discomfort associated with hemorrhoids
  • for the temporary relief of pain
  • 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.

        • Stop use and ask a doctor if

        • condition worsens or does not improve within 7 days
        • in case of bleeding

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: consult a doctor.

Other Information

  • store in cool, dry place away from moisture and direct light

Inactive Ingredients

Acetyl Hexapeptide-8, Butylene Glycol, C13-14 Isoparaffin, Carboxymethylcellulose Sodium, Chloroxylenol, Ethylhexylglycerin, 1,2-Hexanediol, Laureth-7, Pentapeptide-18, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Hyaluronate, Water (Aqua).

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

Tinadaviesicecream (84313002 2)

Tinadaviesicecream (84313002 2)

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