Lidocaine 4% Cream
FDA Label NDC 71800-026

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Innovida Pharmaeutique Corporation for the product Lidocaine 4% (NDC 71800-026). 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, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 4%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain and itching, associated with minor burns,sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.

Warnings

For external Use only

  • Avoid contact with the eyes.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.

    • Stop Use and Ask a Doctor if

    • condition worsens or if symptoms persist for more than 7 days 
    • or occur again within a few days.

      • 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 of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: Do not use, consult a doctor.

Other Information

Store at room temperature, 20 – 25°C (68-77°F).

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE,Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorabte-20, Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Triethanolamine.

Product Label

Image Description (Image 26)

Image Description (Image 26)

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