Lidocaine
FDA Label NDC 75834-113

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 75834-113). 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, warnings, otc - when using, 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

Active Ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

Helps relieve the pain, itching, and burningassociated with hemorrhoids and other anorectal disorders.

Warnings

For external use only.

Otc - When Using

When using this product

  • avoid contact with eyes
  • 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

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.

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.
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other Information

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

Inactive Ingredients

benzyl alcohol,carbomer hompolymer type C, C10-18 triglycerides, cholesterol, lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopherol, trolamine, water

Questions?

1-877-977-0687

Principal Display Panel - 30 G Tube Carton

NDC 75834-113-30

Lidocaine 5%
Anorectal Cream

Relieves:

  • ✓Pain
  • ✓Itching
  • ✓Burning

    • NIVAGEN
    PHARMACEUTICALS

    net wt. 30 g (1 oz)

    Principal Display Panel (30 g Tube Carton)

    Principal Display Panel (30 g Tube Carton)

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