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Lidocaine and Mineral Oil and Phenylephrine Hcl and White Petrolatum

OTC Topical RxCUI 1745450
Contents

Overview

Active ingredient
Lidocaine, Mineral Oil, Phenylephrine Hydrochloride, Petrolatum
Established class
Amide Local Anesthetic; Antiarrhythmic
Physiologic effect
Local Anesthesia
Chemical structure
Amides
Route
Topical
Label date
2024-12-17

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

Purpose

Lidocaine 5% w/w....................................Local anesthetic Mineral Oil 17% w/w................................Protectant Phenylephrine HCl 0.25% w/w.................Vasoconstrictor White Petrolatum 39% w/w.....................Protectant

Dosage and administration

Directions 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 soft cloth before applying. adults and children 12 years and older: apply externally to the affected area up to 4 times daily children under 12 years of age: consult a doctor To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

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.

Ask a doctor before use if

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

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

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

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

Pregnancy or breast-feeding

If pregnant or breastfeeding, ask a doctor before use.

Active ingredient (label)

s Lidocaine 5% w/w Mineral Oil 17% w/w Phenylephrine HCl 0.25% w/w White Petrolatum 39% w/w

Inactive ingredients

s ceteth 20, cetostearyl alcohol, citric acid, propylparaben, purified water

Storage and handling

Other information Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]

Keep out of reach of children

of children. If swallowed, get medical help or contact a Poison Control Center right away.