Icequake Lidocaine Analgesic Liquid
FDA Label NDC 69822-430

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Southern Sales & Service, Inc. for the product Icequake Lidocaine Analgesic (NDC 69822-430). 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 drug facts, active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor ifcondition worsens, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Drug Facts

Active Ingredient

Lidocine HCl 4%

Purpose

Topical anesthetic

Use

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor
    • on large areas of the body or on cut, irritatred or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

When Using This Product

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to area of use

Stop Use And Ask A Doctor Ifcondition Worsens

  • symptoms persist for more than 7 days or clear up and occur again within a few days

Flammable

keep away from fire or flame

If Pregnant Or Breast-Feeding

ask a health professional before use.

Keep Out Of Reach Of Children

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

Directions

  • adults and children over 12 years:
  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

    children 12 years or younger: ask a doctor

Inactive Ingredients

Disodium EDTA, isopropyl alcohol, glycerin, methylparaben, polysorbate 20, propylparaben, purified water, xanthan gum.

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