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  5. Label Information: Burn Relief Leader

FDA Label for Burn Relief Leader

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. DOSAGE & ADMINISTRATION
    5. INACTIVE INGREDIENT
    6. OTC - PURPOSE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burn Relief Leader Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Lidocaine 0.50%


Indications & Usage



Uses

Temporarily relieves pain and itching due to:  sunburn, minor burns, minor cuts, scrapes, insect bites, minor skin irritations.


Warnings



Warnings

For external use only.  Flammable:  do not use while smoking or near heat or flame.  Do not use in large quantities, particularly over raw surfaces or blistered areas.  When using this product:  keep out of eyes, use only as directed, do not puncture or incinerate.  Contents under pressure.  Do no store at temperatures above 120 deg F. Stop use and ask doctor if:  condition gets worse, symptoms last more than 7 days, or symptoms clear up and occur again in a few days. 


Dosage & Administration



Directions

Shake well.  Adults and children 2 years of age and older:  apply to affected area not more than 3 to 4 times daily.  Children under 2 years of age:  ask a doctor.  To apply to face, spray into palm of hand and gently apply.


Inactive Ingredient



Inactive ingredients

Aloe Barbadensis Leaf Juice, SD Alcohol 40, Propylene Glycol, Glycerin, Simethicone, Tocopheryl Acetate, Triethanolamine, Carbomer, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium Cocoamphodipropionate, Disodium EDTA.


Otc - Purpose



Purpose

External analgesic.


Otc - 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.


Package Label.Principal Display Panel



Burn Relief Spray with Lidocaine.

Can image - can

Can image - can



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