lidocaine 5% anorectal cream

lidocaine 5% anorectal cream
SPL v2
SPL
SPL Set ID ceedce20-5723-5a9a-e053-2a95a90a17a1
Routes
rectal topical
Published
Effective Date 2021-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (5 g)
Inactive Ingredients
polysorbate 80 hydrogenated soybean lecithin isopropyl myristate benzyl alcohol carbomer 940 propylene glycol alpha-tocopherol acetate water trolamine

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2021-11-01
Description

Lidocaine 5% w/w

Medication Information

Warnings and Precautions

When using this product

  • Avoid contact with eyes
  • Do not exceed recommended dosage unless directed by a doctor
Active Ingredient

Lidocaine 5% w/w

Directions
  • When practical, clean 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 6 times a day.
  • Children under 12 years of age: Consult a doctor
Description

Lidocaine 5% w/w

Usage

Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.

Children under 12 years of age: Consult a doctor

Dosage

50 miligrams/gram per application

Section 50565-1

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

Section 50569-3
  • Rectal bleeding occurs
  • Condition worsens or does not improve within 7 days
  • Allergic reaction occurs
  • Redness, irritation, swelling, pain or other symptoms begin or increase
  • Symptoms clear up and return within a few days
Section 51727-6

Benzyl Alcohol, Carbopol 940 (Carbomer 940), Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate (Alpha Tocophferol Acetate)

Section 51945-4

NDC 24689-124-01

Lidocaine 5% Anorectal Cream

Apnar Pharma LP

Net.Wt 30 grams

Section 55105-1

Local Anesthetic

Uses Temporarily relieves pain and itching due to anorectal disorders

Section 60561-8

Store at room temperature 20-25°C (68-77°F); Excursions permitted 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Structured Label Content

Warnings and Precautions (34071-1)

When using this product

  • Avoid contact with eyes
  • Do not exceed recommended dosage unless directed by a doctor
Active Ingredient (55106-9)

Lidocaine 5% w/w

Directions (DIRECTIONS)
  • When practical, clean 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 6 times a day.
  • Children under 12 years of age: Consult a doctor
Usage (USAGE)

Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.

Children under 12 years of age: Consult a doctor

Dosage (DOSAGE)

50 miligrams/gram per application

Section 50565-1 (50565-1)

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

Section 50569-3 (50569-3)
  • Rectal bleeding occurs
  • Condition worsens or does not improve within 7 days
  • Allergic reaction occurs
  • Redness, irritation, swelling, pain or other symptoms begin or increase
  • Symptoms clear up and return within a few days
Section 51727-6 (51727-6)

Benzyl Alcohol, Carbopol 940 (Carbomer 940), Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate (Alpha Tocophferol Acetate)

Section 51945-4 (51945-4)

NDC 24689-124-01

Lidocaine 5% Anorectal Cream

Apnar Pharma LP

Net.Wt 30 grams

Section 55105-1 (55105-1)

Local Anesthetic

Uses Temporarily relieves pain and itching due to anorectal disorders

Section 60561-8 (60561-8)

Store at room temperature 20-25°C (68-77°F); Excursions permitted 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:01:34.402822 · Updated: 2026-03-14T23:01:27.375563