Lidoguard Cream
FDA Label NDC 85231-200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Violacare, Inc. for the product Lidoguard (NDC 85231-200). 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 drug facts, 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

Drug Facts

Active Ingredient                                           Purpose

Lidocaine HCl 4%.............................................Topical Analgesic

Uses

Temporarily relieves pain and itching due to:

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

Warnings

For external use only.

When Using This Product

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces 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

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years: Consult a doctor.

Other Information

  • Store at 20° to 25° C (68° to 77° F); excursions permitted to 15° to 30° C (59° to 86° F)

Lnactive Lngredients

acrylates/c10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, aminomethyl propanol, butylene glycol, cetearyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, phenoxyethanol, steareth-21, water

Questions?

Call 877-227-3137

Principal Display Panel

LidoGuard TM Cream - NDC - 85231-200-30 - Pain Relieving Cream - Topical Analgesic - 1.05 oz (30 g)

Carton Label

"image Description" (Lidocaine Cream 30g Carton Label)

"image Description" (Lidocaine Cream 30g Carton Label)

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054

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