Numb Plus Maximum Strength Anorectal Gel
FDA Label NDC 70907-098

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Seenext Venture Ltd for the product Numb Plus Maximum Strength Anorectal (NDC 70907-098). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop the use and consult doctor if, keep out of reach of children, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 5.00%

Purpose

Anorectal (Hermorrhoidal)

Uses

For temporary relief of local discomfort, itching, pain, soreness, or burning in the perianal area associated with anorectal disorders 

Warnings

For external use only

When Using This Product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop The Use And Consult Doctor If

  • allergic reaction occurs
  • rectal bleeding occurs
  • redness, irritation, swelling, pain, or other symptoms begin or increase
  • condition worsens or does not improve within 7 days

Keep Out Of Reach Of Children

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

If Pregnant Or Breastfeeding,

ask a health professional before use   

Directions

  • Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of product
  • when first opening the jar, twist the cap and peel off the foil seal
  • apply externally to the affected area up to 6 times daily
  • children under 12 years of age: consult a doctor 

Other Information

  • always keep the jar tightly closed
  • protect from freezing
  • store at room temperatures not exceeding 59°F to 86°F (15°C to 30°C)

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Benzyl Alcohol, Carbomer, Dimethyl Isosorbide, Dodecane, Ethylhexylglycerin, Lecithin, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Triethanolamine, Zemea (Corn) Propanediol

Questions Or Comments?

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