Lidocaine Cream
FDA Label NDC 75834-333

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nivagen Pharmaceuticals, Inc. for the product Lidocaine (NDC 75834-333). 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, when using this product, stop use and ask a doctor if, 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 5% w/w

Purpose

Topical anesthetic

Uses

Temporarily relieves the pain and itching due to anorectal disorders.

Warnings

For external use only.

When Using This Product

  • avoid contact with eyes
  • do not use in large quantities, particularly over large surfaces or blistered areas
  • do not exceed recommended 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

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days

Keep Out Of Reach Of Children.

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

Directions

  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

Other Information

Store at 25°C (77°C); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

Verolec HE 60, Benzyl Alcohol, Polysorbate 80, Triethanolamine, Vitamin E Acetate, Carbomer 940, Isopropyl Myristate, Propylene Glycol, Water   

Questions?

1-877-977-0687

Principal Display Panel - 30 G Tube Carton

NDC 75834-333-30

Lidocaine 5%

Topical Anesthetic Cream-Anorectal

NIVAGEN

net wt. 30 g (1 oz) 


Carton (Carton)

Carton (Carton)

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