Health One Pain Relief Cream With Lidocaine 4% Cream
FDA Label NDC 55629-029

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Health One Pain Relief Cream With Lidocaine 4% (NDC 55629-029). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Lidocaine HCI 4%

Purpose

Topical anesthetic

Uses

temporarily relieves minor pain

Warnings

For external use only

Do Not Use

  • on puncture wounds
  • on large areas of the body or on cut, irritated or swollen skin
  • 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 carton.
  • do not allow contact with the eyes and mucous membranes
  • do not bandage or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics

Stop Use And Ask A Doctor If

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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 and younger: ask a doctor

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer,, Aloe Vera Leaf Juice, Trolamine, C30-45 alkyl cetearyl dimethicone crosspolymer, Cetearyl Alcohol, Dimethocane, Edetate Disodium, Ethylhexylglycerin, Glyceryl Monostearate, Methylparaben, Isopropyl Alcohol, Steareth-21, Purified Water

Package Label

* Please review the disclaimer below.