Lidocaine Cream
FDA Label NDC 58980-826

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals Inc for the product Lidocaine (NDC 58980-826). 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, when using this product, stop use and consult a doctor if, if pregnant or breast-feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Lidocaine is NOT approved by FDA to treat teething pain and should NOT be given to infants and young children for this use.

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

Active Ingredient

Lidocaine 3% (3g in 100g)

Purpose

Local analgesic

Uses

for the temporary relief of pain and itching associated with

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

Warnings

For external use only

When Using This Product

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

Stop Use And Consult A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breast-Feeding

Ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If accidentally ingested, get medical help or contact a Poison Control Center immediately.

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: do not use, consult a doctor.

Other Information

Store at 20°C to 25°C (68°F to 77°F)

Inactive Ingredients

acrylamide, allantoin, aloe vera extract, benzyl alcohol, c12-15 alkyl benzoate, carbomer, isohexadecane, polysorbate 80, propylene glycol, purified water, sodium acryloydimethyl taurate, sodium laureth sulfate, soy lecithin, tocopheryl acetate.

Questions?

Call us at (800) 442-7882

Principal Display Panel - 28.35 G Tube Box

STRATUS
PHARMACEUTICALS INC

NDC 58980-826-30

Net WT. 1 oz. / 28.35 g

LIDOCAINE CREAM
3%

PAIN RELIEVING CREAM

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE

Principal Display Panel (28.35 g Tube Box)

Principal Display Panel (28.35 g Tube Box)

* Please review the disclaimer below.