Lidocaine Pain Relief
FDA Label NDC 77338-009

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Astonea Labs Private Limited for the product Lidocaine Pain Relief (NDC 77338-009). 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 ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine HCl 4%

Purpose

Lidocaine HCl - Topical anesthetic

Uses

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

When Using This Product

  • use only as directed
  • do not get into eyes
  • do not bandage tightly or apply external heat (such as a heating pad) to the area of use

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness, rash, or irritation occurs

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact Poison Control Center (800-222-1222) right away.

Directions

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

Inactive Ingredients

aloe vera leaf, carbomer 940, ceteth-20, cetostearyl alcohol, dimethicone, glycerin. glyceryl monostearate, isopropyl alcohol, petrolatum, phenoxyethanol, polysorbate 60, trolamine, water

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