Burn With Aloe
FDA Label NDC 69103-3500

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Provision Medical for the product Burn With Aloe (NDC 69103-3500). 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 ingredient, purpose, uses, warnings, do not use, otc - stop use, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Lidocaine HCI 2,0%

Purpose

Topical pain relief

Uses

temporary pain relief associated with minor burns

Warnings

For external use only.

Do Not Use

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

Otc - Stop Use

Stop use and ask a doctor if condition worsens or persists for more than 7 days or clears up and returns

Keep Out Of Reach Of Children.

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

Directions

  • adults and children 2 years of age and older: spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
  • for children under 2 years of age: consult a physician

Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water

Principal Display Panel - Bottle Label

with aloe vera

BURN SPRAY

Relieves Pain in Minor Burns

Washable

Package Not Child Resistant

2 fl. oz. (59.15ml)

Manufactured for

Provision Medical Products Palm Desert, CA 92211

Principal Display Panel (Bottle Label)

Principal Display Panel (Bottle Label)

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