Alcemiste Cream
FDA Label NDC 87087-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Price Team Ventures, Llc for the product Alcemiste (NDC 87087-001). 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.

Active Ingredient

Lidocaine HCL 4%

Purpose

External Analgesic

Uses

Provides temporary relief from pain and itching caused by sunburns, minor cuts, insect bites, and skin irritations.

Warnings

1. For external use only
2. Avoid contact with the eyes
3. Stop use and consult a doctor if:

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days
  • Avoid excessive use, especially on raw or blistered skin. Do not
    exceed the recommended daily dosage unless advised by a doctor.

    Do not useon wounds or damaged skin.

    Keep out of reach of children.
    If swallowed, seek immediate medical attention or contact a Poison Control Center right away.

Directions

For adults and children aged 2 years and older: Gently apply to the affected area. Up to 3 to 4 times daily as needed.

For children under 2 years: Do not use without consulting a healthcare professional.

Other Information

Don’t use if the seal is tampered.

Inactive Ingredients

Agua (Water), Isopropyl myristate , Glycerin, Ethoxydiglycol , Polyacrylate, Crosspolymer-6, Cyclopentasiloxane, Polysorbate, Phenoxyethanol , Ethylhexylglycerin, Xanthan Gum

Product Label

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