Dynarex Burn Cream
FDA Label NDC 67777-412

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dynarex Corporation for the product Dynarex Burn Cream (NDC 67777-412). 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 ingredients, purpose, uses, warnings, keep out of reach of children, stop use, do not use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Active Ingredient                                       Purpose

Lidocaine HCL 0.5%                                   Topical Analgesic

Benzalkonium Chloride 0.13%                    Topical Antiseptic

Purpose

Temporary relief of pain and itching.

Uses

For temporary relief of pain and itching associated with:

  • Sunburn
  • Minor burns,
  • Insect bites,
  • Minor skin irritation,
  • Cuts and 
  • Scrapes

Warnings

FOR EXTERNAL USE ONLY

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.

Stop Use

Stop Use and ask a doctor:

  • If condition worsens or,
  • if symptoms persist for more than 7 days or clear up and occur again in a few days.
  • If pregnant or breast feeding, ask a health professional before use.

Do Not Use

Do Not Use:

  • In the eyes
  • Over large areas of the body or on deep puncture wounds, animal bites or serious burns.
  • In large quantities, particularly over raw surfaces or blistered areas.

Directions

Adults and children 2 years and over:

  • clean the affected area
  • apply a small amount of this product on the area 3 or 4 times daily.
  • may be covered with a sterile bandage

    • Children under 2 years

    • consult a doctor

Inactive Ingredients

Buttylated hydroxy toluene, Cetomacrogol, Cetostearyl alcohol, Dimethicone, Glycerine, Glyceryl monostearate, Isopropyl myristate, Methylcellulose, Purified water, Sodium EDTA, Sodium methylparaben, Sodium propylparaben

Other Information

Other Information

  • store in a cool, dry area
  • 59o to 79o F (15o to 25o C)
  • Tamper evident sealed packets do not use any open or torn packets

Principal Display Panel

Dynarex Burn Cream 

DFAC.jpg

Burn Cream (Dfac)

Burn Cream (Dfac)

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