Lidocaine 4% Cream
FDA Label NDC 82461-419

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medcore Llc for the product Lidocaine 4% Cream (NDC 82461-419). 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, keep out of reach of children., directions, other information, inactive ingredients, 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:

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

Warnings

For external use only.

When using this product

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • do not use If pregenant or breastfeeding.

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

Adults and children 12 years and older:

Apply externally to the affected area up to 6 times a day.

children under 2 years ask a doctor

Other Information

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature

Inactive Ingredients

STEARIC ACID , GLYCERYL-STEARATE, PEG-100 STEARATE , SODIUM POLYACRYLATE , GLUCOSAMINE SULFATE , TROLAMINE , LAURETH, ISOSTEARYL PALMITATE, PROPYLENE GLYCOL , DIMETHYL SULFONE , C13-14 ISOPARAFFIN, PHENOXYETHANOL, POLYACRYLAMIDE, CETOSTEARYL ALCOHOL , CHONDROITIN SULFATE , Pure Water, Peppermint oil

Stop Use And Ask A 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

Manufactured For:

Medcore LLC 3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

Package Label.Principal Display Panel

NDC:82461-419-30

Lidocaine 4%
Topical Anesthetic Cream

Medcore LLC

30 gram

Lidocaine 4% (Lidocaine 01)

Lidocaine 4% (Lidocaine 01)

Lidocaine 4% (Lidocaine 02)

Lidocaine 4% (Lidocaine 02)

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