Lidocaine Anesthetic Cream
FDA Label NDC 69375-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nationwide Pharmaceutical Llc for the product Lidocaine Anesthetic Cream (NDC 69375-005). 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 other, active ingredients, purpose, uses, warnings, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

Active Ingredients

Lidocaine 4% w/w

Purpose

Local Anesthetic

Uses

For temporary relief of pain associated with minor cuts, minor burns, minor scrapes, sunburn, minor skin irritations, and insect bites.

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 use in large quantities, particularly over raw or blistered areas.

Stop Use And Ask A Doctor If

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.

Directions

  • Adults and children 2 years and older. Apply externally to the affected area up to 3 to 4 times a day.
  • Children under 2 years of age. Consult a doctor.

Other Information

Store at USP controlled room temperature 20-25 °C (68-77 °F).

Inactive Ingredients

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

Questions?

1-800-697-3329

Principal Display Panel - 28 G Tube Box

Nationwide
Pharmaceutical

NDC 69375-0005-30

4% Lidocaine
Topical Anesthetic Cream

NET WT 1 oz ( 28 g)

Principal Display Panel (28 g Tube Box)

Principal Display Panel (28 g Tube Box)

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