Astonea Burn Cream
FDA Label NDC 77338-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Astonea Labs Private Limited for the product Astonea Burn Cream (NDC 77338-100). 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, do not use, stop use, if pregnant or breast feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Active Ingredients

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Purpose

Topical Analgesic

Topical Antiseptic

Uses

For temporary relief of pain and itching associated with:

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

Warnings

FOR EXTERNAL USE ONLY

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.

Stop Use

•the condition gets worse •condition clears up and recurs within a few days •condition persists for more than 7 days

Keep Out Of Reach Of Children

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

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

Other Information

•store in a cool, dry area 59°-86°F (15°-30°C) •tamper evident sealed packets do not use any opened or torn packets

Inactive Ingredients

Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, Purified water, Stearic acid, Triethanolamine.

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