Rectasmoothe Cream
FDA Label NDC 69315-301

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Leading Pharma, Llc for the product Rectasmoothe (NDC 69315-301). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings:, when using this product, stop use and ask doctor if, keep out of the reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient


Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

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

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.

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.

Other Information

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

Inactive Ingredients

cetyl alcohol, glyceryl monostearate SE, methylparaben, propylene glycol, propylparaben, purified water, white petrolatum, white wax

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