Dr. Numb Cream
FDA Label NDC 69903-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shinpharma Inc for the product Dr. Numb (NDC 69903-001). 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, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 5%

Lidocaine 5%

Purpose


Anorectal (Hemmorhoidal)


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 worsenss 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

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 tube, puncture foil seal with top end of cap
  • 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 tube tightly closed
  • store at temperature not exceeding 15OC - 30OC
  • protect from freezing

Inactive Ingredients

Benzyl Alcohol, Carbomer 934, Lecithin(Soybean), Propylene Glycol, Tocopheryl Acetate, Water.

Question Or Comments


Call weekdays 9 AM to 6 PM PST at 1-877-786-2001 or email us at [email protected] 

Principal Display Panel

NDC 69903-001-30

Prompt, Soothing Relief from Painful Burning, Itching and Discomfort

5% Lidocaine Cream

For External Use Only

Dr. Numb Lidocaine Cream

RAPID ABSORPTION

Maximum Strength Pain Reliever

30g

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