Lidocaine Cream
FDA Label NDC 80425-0351

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Pharmacy Of Tennessee, Llc for the product Lidocaine (NDC 80425-0351). 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 ingredient, purpose, uses, directions, otc - do not use, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

For external use only.

Active Ingredient

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to

  • minor cuts
  • minor scrapes
  • minor burns
  • sunburn
  • minor skin irritation
  • insect bites

Directions

  • Adult 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.

Otc - Do Not Use

Do not use

  • in or near the eyes
  • 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 - Keep Out Of Reach Of Children

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

Other Information

  • May be applied under occlusive dressing.
  • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

Benzyl Alcohol, Carbopol 940, Hydrogenated Lecithin, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine and Vitamin E Acetate.

Questions?

Call 800-936-3088

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