Careall First Aid Burn Cream
FDA Label NDC 51824-096

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall First Aid Burn Cream (NDC 51824-096). 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, keep out of reach of children, uses, warnings, pregnant or breast feeding, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

Benzalkonium Chloride 0.13%.....First Aid Antiseptic

Lidocaine HCl 0.5%....................External Analgesic

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

Uses

First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns

Warnings

For external use only.

Do not use:

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor 
  • in large quantities, particularly over raw surfaces or blistered areas

    • Ask a doctor before use if you have:

    • deep or puncture wounds
    • animal bites
    • serious burns

      • Stop use and ask a doctor if:

      • condition worsens or clears up and occurs again within a few days
      • symptoms persists for more than 7 days

Pregnant Or Breast Feeding

If pregnant or breast feeding, ask a health professional before use

Directions

Adults and children 2 years of age and older:

  • clean the affected area
  • apply a small amount of this product not more than 3 times daily
  • may be covered with sterily bandage

    • Children under 2 years of age: do not use, consult a doctor

Inactive Ingredients

Butylated Hydroxytoluene, Ceteareth 20, Cetostearyl Alcohol, Dimethicone (100 CST), Edetate Disodium Dihydrate, Glycerin, Glyceryl Monostearate, Hypromellose, Isopropyl Myristate, Methylparaben Sodium, Propylparaben Sodium, Purified Water

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