Numb520

Numb520
SPL v3
SPL
SPL Set ID a0411950-c6ee-4427-acb6-3cef58b0e93e
Route
TOPICAL
Published
Effective Date 2021-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Allantoin Aloe Vera Leaf Benzyl Alcohol Carbomer Homopolymer, Unspecified Type Cholesterol Dimethyl Isosorbide Edetate Disodium Anhydrous Neopentyl Glycol Dicaprylate/dicaprate Propylene Glycol Water .alpha.-tocopherol Acetate Trideceth-6 Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-01
Description

Lidocaine 5%

Purpose

Local Anesthetic

Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5%

Uses:

for the temporary relief of local and anorectal discomfort associated with anorectal disorders or inflammation.

Warnings

(For external use only)

Directions
  • 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 soft cloth, before application of this product.
  • Apply up to 6 times a day.
  • Children under 12 years of age: consult a doctor. 
Do Not Use

this product if

  • pregnant or breastfeeding, ask a health professional before use.
  • in case of accidental overdose, get medical help or contact the Poison Control Center immediately.
  • seal is broken or missing.
Active Ingredient

Lidocaine 5%

Other Information
  • keep away from direct sunlight or heat.
  • store at room temperature 15°-30°C (59°-86°F).
Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Water, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine

When Using This Product
  • do not exceed the recommended daily dosage unless directed by a doctor.
  • certain persons can develop allergic reactions to ingredients in this product.
  • do not put this product into the rectum by using finger or any medical device or applicator.
Stop Use and Ask A Doctor If

the symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep Out of Reach of Children

In case of accidental ingestion, seek medical attention immediately.

Package Labeling:63742 033 01 38g

Package Labeling:63742 033 02 125g

Structured Label Content

Uses:

for the temporary relief of local and anorectal discomfort associated with anorectal disorders or inflammation.

Purpose

Local Anesthetic

Warnings

(For external use only)

Directions
  • 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 soft cloth, before application of this product.
  • Apply up to 6 times a day.
  • Children under 12 years of age: consult a doctor. 
Do Not Use (Do not use)

this product if

  • pregnant or breastfeeding, ask a health professional before use.
  • in case of accidental overdose, get medical help or contact the Poison Control Center immediately.
  • seal is broken or missing.
Active Ingredient

Lidocaine 5%

Other Information
  • keep away from direct sunlight or heat.
  • store at room temperature 15°-30°C (59°-86°F).
Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Water, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine

When Using This Product (When using this product)
  • do not exceed the recommended daily dosage unless directed by a doctor.
  • certain persons can develop allergic reactions to ingredients in this product.
  • do not put this product into the rectum by using finger or any medical device or applicator.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

the symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, seek medical attention immediately.

Package Labeling:63742 033 01 38g (Package Labeling:63742-033-01 38g)

Package Labeling:63742 033 02 125g (Package Labeling:63742-033-02 125g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:08.590544 · Updated: 2026-03-14T23:08:46.104923