Initial Drug Listing - Nupharmisto Numbmd Lidocaine Cream Anorectal (hemorrhoidal)

Initial Drug Listing - Nupharmisto Numbmd Lidocaine Cream Anorectal (hemorrhoidal)
SPL v1
SPL
SPL Set ID 483d81a3-7493-3391-e063-6394a90a2e3d
Route
TOPICAL
Published
Effective Date 2026-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Lecithin, Soybean Arnica Montana .alpha.-tocopherol Acetate Aqua Propylene Glycol Emu Oil Carbomer 934 Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-27
Description

Lidocaine 5%

Medication Information

Warnings and Precautions

For external use only

  • If condition worsens or does not improve within 7 days,consult a doctor.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • In case of bleeding,consult a doctor promptly.
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Indications and Usage
  • Adults: 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 a sof tcloth before application of this product.
  • Apply to the affected area up to 6 times daily.
  • Children under 12years of age: consult a doctor.
Dosage and Administration

For the temporary relief of local itching and discomfort associated with anorectal disorders. For the temporary relief of pain,burning and soreness.

Description

Lidocaine 5%

Section 50565-1

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

Section 50569-3
  • an allergic reaction occurs
  • symptom does not improve or ifredness, irritation, swelling, pain or othe rsymptoms develop or increase.
Section 51727-6

Carbomer 934, Lecithin(Soybean), Emu Oil,Arnica, Propylene Glycol, Tocopheryl Acetate,Benzyl Alcohol, Aqua.

Section 51945-4

Section 53413-1
Section 53414-9

Ask a health professional before use.

Section 55105-1

Local Anorectal(hemorrhoidal) Anesthetic

Section 55106-9

Lidocaine 5%

Section 60561-8

Store at room temperature 59-86F(15-30C). Keep away from direct sunlight or heat.

Structured Label Content

Indications and Usage (34067-9)
  • Adults: 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 a sof tcloth before application of this product.
  • Apply to the affected area up to 6 times daily.
  • Children under 12years of age: consult a doctor.
Dosage and Administration (34068-7)

For the temporary relief of local itching and discomfort associated with anorectal disorders. For the temporary relief of pain,burning and soreness.

Warnings and Precautions (34071-1)

For external use only

  • If condition worsens or does not improve within 7 days,consult a doctor.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • In case of bleeding,consult a doctor promptly.
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Section 50565-1 (50565-1)

In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.(1-800-222-1222)

Section 50569-3 (50569-3)
  • an allergic reaction occurs
  • symptom does not improve or ifredness, irritation, swelling, pain or othe rsymptoms develop or increase.
Section 51727-6 (51727-6)

Carbomer 934, Lecithin(Soybean), Emu Oil,Arnica, Propylene Glycol, Tocopheryl Acetate,Benzyl Alcohol, Aqua.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Local Anorectal(hemorrhoidal) Anesthetic

Section 55106-9 (55106-9)

Lidocaine 5%

Section 60561-8 (60561-8)

Store at room temperature 59-86F(15-30C). Keep away from direct sunlight or heat.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:22.142982 · Updated: 2026-03-14T23:12:35.594126