First Aid And Burn
FDA Label NDC 50607-5700

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by B8 Sales, Inc. for the product First Aid And Burn (NDC 50607-5700). 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 ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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First Aid & Burn CreamTM

  • For Temporary Relief of Pain Associated with Minor Burns
  • Helps Protect Against Harmful Bacteria

    • 25 Packets

    Each Packet Net.Wt.0.9gm

Active Ingredients

Benzalkonium Chloride 0.13%

Lidocaine HCI 0.5%

Purpose

First Aid Antiseptic

Topical Analgesic

Uses

  • for the temporary relief of pain associated with minor bums
  • helps protect against harmful bacteria

Warnings

For external use only.

Keep out of reach of children.

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

Do Not Use

  • in eyes ■ in large quantities ■ over raw or blistered areas, or on deep puncture wounds, animal bites, serious burns
  • for more than one week unless directed by a doctor

Stop Use And Ask A Doctor If

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

Directions

Adults and children 2 years and over: clean affected area, apply small amount not more than 3 to 4 times daily Children under 2 years: do not use, consult a doctor

Other Information

  • store at room temperature (do not freeze)
  • do not use any opened or torn packets

Inactive Ingredients

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

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First Aid & Burn Cream – Carton Label

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First Aid & Burn CreamTM

  • For Temporary Relief of Pain Associated with Minor Burns
  • Helps Protect Against Harmful Bacteria

    • 25 Packets

    Each Packet Net.Wt.0.9gm

    First Aid & Burn Cream – Carton Label (Fa Burn Cm 01)

    First Aid & Burn Cream – Carton Label (Fa Burn Cm 01)

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