BURN RELIEF LEADER- lidocaine spray

Burn Relief by

Drug Labeling and Warnings

Burn Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PURPOSE

Purpose

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.

PRINCIPAL DISPLAY PANEL

Burn Relief Spray with Lidocaine.

INGREDIENTS AND APPEARANCE

BURN RELIEF  LEADER
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-613
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Aloe (UNII: V5VD430YW9)
Alcohol (UNII: 3K9958V90M)
Propylene Glycol (UNII: 6DC9Q167V3)
Glycerin (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Edetate Disodium (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-613-11	127 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	12/01/2011

Labeler - Cardinal Health (097537435)