Lidocaine Cream
FDA Label NDC 10135-672

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marlex Pharmaceuticals Inc for the product Lidocaine (NDC 10135-672). 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, use, warnings, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Lidocaine 4%

Purpose

Pain & Itch Relief

Use

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

Warnings

For external use only. Avoid contact with eyes. Not for prolonged use.

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • rash or irritation develops, persists, or increases

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

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: Consult a doctor

Other Information

  • May be applied under occlusive dressing
  • store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) 

Inactive Ingredients

Benzyl alcohol, carbopol 940, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine and vitamin E acetate

Principal Display Panel - 15G Tube Carton

Lidocaine 4% Topical Anesthetic Cream

Pain & Itch Relief Cream NET WT. 0.5 oz.(15g)

Principal Display Panel (15g Tube CartonLidocaine 4% Topical Anesthetic CreamPain & Itch Relief Cream NET WT. 0.5 oz.(15g))

Principal Display Panel (15g Tube CartonLidocaine 4% Topical Anesthetic CreamPain & Itch Relief Cream NET WT. 0.5 oz.(15g))

Principal Display Panel - 30G Tube Carton

Lidocaine 4% Topical Anesthetic Cream

Pain & Itch Relief Cream NET WT. (30g)

Principal Display Panel (30g Tube CartonLidocaine 4% Topical Anesthetic CreamPain & Itch Relief Cream NET WT. (30g))

Principal Display Panel (30g Tube CartonLidocaine 4% Topical Anesthetic CreamPain & Itch Relief Cream NET WT. (30g))

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