Dr. Numb Cream
FDA Label NDC 69903-003

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 69903-003). 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 4% w/w

Purpose

Topical Anesthetic

Uses

Temporarily relieves pain and itching due to

  • insect bites
  • minor burns
  • minor cuts
  • minor scrapes
  • minor skin irritations
  • sunburn

Warnings

For external use only

When Using This Product

  • avoid contact with the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

Stop The Use And Consult Doctor If

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep Out Of Reach Of Children

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

Directions

  • Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day
  • Children under 2 years: Consult a doctor

Other Information

  • May be applied under occlusive dressing. 
  • Store at 25 ̊C (77 ̊F);
  • excursions permitted to 15-30 ̊C (59-86 ̊F) [see USP Controlled Room Temperature].

Inactive Ingredients

Benzyl Alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Trolamine, Vitamin E Acetate, Water

Question Or Comments

Contact our dedicated Customer Care at +1(877) 786 2001 or email us at [email protected] within 24 hours a day, from Monday to Saturday Pacific Time.

Principal Display Panel

NDC 69903-003-30

Water-based, Hypoallergenic and Fast Penetrating Topical Pain Relief and Anti-Itch Formula

Apply to the skin to relieve pain

FOR EXTERNAL USE ONLY

Dr. Numb

TOPICAL ANESTHETIC CREAM

Lidocaine 4% Cream -  Topical Anesthetic

30g

Label (30)

Label (30)

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