Tina Davies IceCream

LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE TOPICAL HUMAN OTC DRUG

Tina Davies IceCream is an FDA drug label for the active ingredient LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE manufactured by TINA DAVIES PROFESSIONAL LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260709.

Generic name
LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Manufacturer
TINA DAVIES PROFESSIONAL LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
84313-001
Application
M015
Label effective
20260709

About this product

Tina Davies IceCream is an FDA-registered drug product whose active ingredient is LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE. It is labelled by TINA DAVIES PROFESSIONAL LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84313-001, application M015, label effective 20260709. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE are most often described in connection with: temporary relief, anorectal itching, discomfort associated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredients Lidocaine HCl 5% Phenylephrine HCl 0.25%

Indications & Usage

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

Dosage & Administration

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.

Warnings

Warnings For external use only Allergy alert: Certain persons can develop allergic reactions to ingredients in this product. 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, or 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. • Bleeding occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently asked questions

What is Tina Davies IceCream used for?
Uses • For the temporary relief of anorectal itching and discomfort associated with hemorrhoids. • For temporary relief of pain.

Who makes Tina Davies IceCream?
TINA DAVIES PROFESSIONAL LLC is the labeler of record for Tina Davies IceCream.

What form does Tina Davies IceCream come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Tina Davies IceCream prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has Tina Davies IceCream been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.