Lidocaine Hydrochloride, Phenylephrine Hydrochloride

FDA Drug Profile — Tina Davies IceCream

Drug Details

Generic Name
Lidocaine Hydrochloride, Phenylephrine Hydrochloride
Brand Names
Tina Davies IceCream
Application Number
M015
Sponsor
TINA DAVIES PROFESSIONAL LLC
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

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

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.