RectaSmoothe LIDOCAINE 5% LEADING PHARMA, LLC FDA Approved Uses Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.
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Substance Lidocaine
Route
TOPICAL
Applications
PART346
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient Lidocaine 5% w/w
Inactive Ingredients
Inactive Ingredients cetyl alcohol glyceryl monostearate SE methylparaben propylene glycol propylparaben purified water white petrolatum white wax
Strengths
5 %
Treats Conditions
Uses Helps Relive The Pain Itching And Burning Associated With Hemorrhoids And Other Anorectal Disorders

Identifiers & Packaging

Container Type BOX
All Product Codes
UPC
0369315301302
UNII
98PI200987
Packaging

Lidocaine 5% Label Carton

Package Descriptions
  • Lidocaine 5% Label Carton

Overview

Uses Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Indications & Usage

Uses Helps relive the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

Dosage & Administration

Directions When practical, clean area with mild soap and warm water and rinse thouroughly. 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 six times a day. Children under 12 years of age: Consult a doctor To use finger cots: Roll one finger cot over finger. FGently squeeze cream onto finger cot. Smooth a layer of the cream over the affected area.

Warnings & Precautions
WARNINGS: For external use only. When using this product avoid contact with the eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any other mechanical device or applicator Stop use and ask doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product symptom being treated does not suside or if redness, irritation swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.
Purpose

Purpose Local anesthetic

When Using

When using this product avoid contact with the eyes do not exceed recommended dosage unless directed by a doctor do not put this product into the rectum by using fingers or any other mechanical device or applicator Stop use and ask doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product symptom being treated does not suside or if redness, irritation swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Keep Out of Reach of Children

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

Storage & Handling

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


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