Numb520 Spray

Numb520 Spray
SPL v5
SPL
SPL Set ID 65d3b614-361d-4fb9-9583-a95be754bc82
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) Phenylephrine (2.5 mg)
Inactive Ingredients
Allantoin Arginine Benzyl Alcohol Edetate Disodium Anhydrous Diethylene Glycol Monoethyl Ether Phenoxyethanol Polysorbate 20 Water Sodium Benzoate Sodium Sulfite

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-26

Description

Lidocaine 5% Phenylephrine HCL 0.25%

Purpose

Local Anesthetic Vasoconstrictor


Medication Information

Purpose

Local Anesthetic

Vasoconstrictor

Description

Lidocaine 5% Phenylephrine HCL 0.25%

Uses:

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

Warnings
  • for external use only.
  • avoid contact with the eyes.
Directions
  • clean the affected area.
  • sensitivity and possible allergy tests advised prior to use. Spray sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs. You may reapply to continue numbing effect.
  • apply to the affected area up to 4 times daily.
  • children under 12 years of age: consult a doctor. 
Do Not Use

this product if

  • pregnant or breastfeeding, ask a health professional before use.
  • seal is broken or missing.
  • you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.
Active Ingredient

Lidocaine 5%

Phenylephrine HCL 0.25%

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

Inactive Ingredients

Allantoin, Arginine, Benzyl Alcohol, Disodium EDTA, Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Water, Sodium Benzoate, Sodium Sulfite

When Using This Product
  • do not exceed the recommended daily usage.
  • 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.
  • if swallowed, call your Poison Control Center at 1(800) 222 1222.
  • If condition worsens or does not improve within 7 days, consult a doctor.
Stop Use and Ask A Doctor If
  • the symptom being treated does not subside, or redness, irritation, swelling, pain, or other symptoms develop or increase.

Structured Label Content

Uses:

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

Purpose

Local Anesthetic

Vasoconstrictor

Warnings
  • for external use only.
  • avoid contact with the eyes.
Directions
  • clean the affected area.
  • sensitivity and possible allergy tests advised prior to use. Spray sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs. You may reapply to continue numbing effect.
  • apply to the affected area up to 4 times daily.
  • 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.
  • seal is broken or missing.
  • you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.
Active Ingredient

Lidocaine 5%

Phenylephrine HCL 0.25%

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

Inactive Ingredients

Allantoin, Arginine, Benzyl Alcohol, Disodium EDTA, Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Water, Sodium Benzoate, Sodium Sulfite

When Using This Product (When using this product)
  • do not exceed the recommended daily usage.
  • 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.
  • if swallowed, call your Poison Control Center at 1(800) 222 1222.
  • If condition worsens or does not improve within 7 days, consult a doctor.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • the symptom being treated does not subside, or redness, irritation, swelling, pain, or other symptoms develop or increase.

Advanced Ingredient Data


Raw Label Data

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