Numb And Number Anorectal Cream

Numb And Number Anorectal Cream
SPL v1
SPL
SPL Set ID 31420635-5021-173d-e063-6294a90a407a
Route
TOPICAL
Published
Effective Date 2025-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Water Cetearyl Alcohol Ceteth-20 Cholesterol Propanediol Carbomer Lecithin, Soybean Ppg-12/smdi Copolymer Benzyl Alcohol Aminomethyl Propanol Ethoxydiglycol Polysorbate 60

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-26

Description

Active ingredients Purpose Lidocaine 5% .........Local Anesthetic


Medication Information

Warnings and Precautions

Warnings

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

Indications and Usage

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
Dosage and Administration

Directions

  • Adults: when practical, clean 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. Apply externally to the affected area up to 6 times a day.
  • Children 12 and under, consult a physician prior to use.
Description

Active ingredients Purpose Lidocaine 5% .........Local Anesthetic

Section 50565-1

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

Section 51727-6

Inactive Ingredients

Aminomethyl Propanol, Benzyl Alcohol, Carbomer, Cetearyl Alcohol, Ceteth-20, Cholesterol, Ethoxydiglycol, Lecithin, Polysorbate 60, PPG-12/SMDI Copolymer, Propanediol, Water.

Section 51945-4

numb & number

Local Anesthetic

anorectal cream

Net Wt 1.8 oz / 54g

Section 55105-1

Uses Temporary relief of pain, itching and discomfort associated with hemmrroids

Section 55106-9

Active ingredients Purpose

Lidocaine 5% .........Local Anesthetic


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
Dosage and Administration (34068-7)

Directions

  • Adults: when practical, clean 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. Apply externally to the affected area up to 6 times a day.
  • Children 12 and under, consult a physician prior to use.
Warnings and Precautions (34071-1)

Warnings

For external use only.

If pregnant or breast-feeding, ask a health professional before use.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients

Aminomethyl Propanol, Benzyl Alcohol, Carbomer, Cetearyl Alcohol, Ceteth-20, Cholesterol, Ethoxydiglycol, Lecithin, Polysorbate 60, PPG-12/SMDI Copolymer, Propanediol, Water.

Section 51945-4 (51945-4)

numb & number

Local Anesthetic

anorectal cream

Net Wt 1.8 oz / 54g

Section 55105-1 (55105-1)

Uses Temporary relief of pain, itching and discomfort associated with hemmrroids

Section 55106-9 (55106-9)

Active ingredients Purpose

Lidocaine 5% .........Local Anesthetic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)