Regenecare Ha Gel
FDA Label NDC 66977-117

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mpm Medical Llc for the product Regenecare Ha (NDC 66977-117). 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, directions, other information, inactive ingredients, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine HCl 2%

Purpose

Anesthetic

Uses

For the temporary relief of pain and itching associated with

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

Warnings

For external use only

If swallowed, get medical help or contatct a Poison Control Center right away

Avoid contact with the eyes

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult with a doctor

Do not use in large quantities, particularly over raw surfaces or blistered areas

Directions

Adults and children 2 years of age and older:  Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age:  Consult a physician prior to use.

Other Information

Store at room temperature.

Avoid freezing and excessive heat.

Inactive Ingredients

Aloe vera barbadensis leaf extract, Benzethonium chloride, Carbomer, Glycerin, Iodopropynyl butylcarbamate, Procollagen, Sodium hyaluronate, Triethanolamine, Water

Package Label

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