Lidocaine Cream, 4% Cream
FDA Label NDC 71085-075

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ipg Pharmaceuticals, Inc. for the product Lidocaine Cream, 4% (NDC 71085-075). 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, purposes, uses, directions, warning, 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%

Purposes

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.

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.

Warning

Warnings for External Use only

  • Avoid contact with eyes
  • Do not use in large quantities, particularly over raw surface or blistered area


    • 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.

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 75)

Image Description (Image 75)

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