Etaderm Numbing Cream
FDA Label NDC 84180-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuephase Llc for the product Etaderm Numbing Cream (NDC 84180-001). 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 ingredients, purpose, uses:, warnings:, when using this product, stop use and ask a doctor if, keep out of reach of children., if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Lidocaine 5 %

Purpose

Local Anesthetic

Uses:

For temporary relief of local and Anorectal discomfort associated with Anorectal discomfort or inflammation

Warnings:

For external use only

When Using This Product

  • ▪ do not get into eyes. ▪ do not exceed the recommended daily dosage unless directed by a doctor ▪ do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop Use And Ask A Doctor If

  • ▪ condition worsens or does not improve within 7 days. ▪ in case of bleeding, consult a doctor promptly ▪ Certain persons can develop
    allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions:

▪ Cleanse affected area and gently dry. Apply externally to the affected area up to 6 times daily, especially at night, in the morning or after each bowel movement ▪ Children under 12 years of age: consult a doctor.

Inactive Ingredients:

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate.

Questions?

424-354-4370

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