Dr. Numb Cream
FDA Label NDC 69903-003

12 label sections · Submitted to the FDA by Shinpharma Inc · 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 our 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

→ Purpose

→ Uses

→ Warnings

→ When Using This Product

→ Stop The Use And Consult Doctor If

→ Keep Our Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Question Or Comments

→ Principal Display Panel

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 Our 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°C -30°C (59°F - 86°F) [see USP Controlled Room Temperature].