lidocaine and mineral oil and phenylephrine HCl and white petrolatum

FDA Drug Profile — Recticare Advanced

Drug Details

Generic Name
lidocaine and mineral oil and phenylephrine HCl and white petrolatum
Brand Names
Recticare Advanced
Application Number
M015
Sponsor
Ferndale Laboratories, Inc.
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
LIDOCAINE, MINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE

Indications and Usage

Uses helps relieve the pain, itching and burning associated with hemorrhoids temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders temporarily provides a coating for relief of anorectal discomforts temporarily protects irritated areas and inflamed perianal skin

Warnings

Warnings For external use only. 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 avoid contact with eyes do not exceed 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 bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breastfeeding, ask a doctor before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.