BURN RELIEF- lidocaine spray

Burn Relief by

Drug Labeling and Warnings

Burn Relief by is a Otc medication manufactured, distributed, or labeled by Amerisource Bergen, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                     Purpose
Lidocaine 0.5%.........................External analgesic

PURPOSE

INDICATIONS & USAGE

Uses

For the temporary relief of pain and itching associated with: sunburn
minor burns minor cuts scrapes insect bites minor skin irritations

WARNINGS

Warnings
For external use only.
Flammable: Do not use near heat, flame, or while smoking.
Do not use in large quantities, particularly over raw surfaces or blistered areas.
When using this product keep away from face to avoid breathing it. avoid
contact with eyes. use only as directed. do not puncture or incinerate.
Contents under pressure. Do not store at temperatures above 120ºF.
If condition worsens or if symptoms persist for more than 7 days or clear up and
occur again within a few days, discontinue use of this product and consult a doctor.

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.

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:
consult a doctor Do not spray directly into face; spray into palm of hand and
gently apply

INACTIVE INGREDIENT

Inactive ingredients

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

Questions? 610-727-7000

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN RELIEF 
lidocaine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24385-777
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	Lidocaine	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Aloe (UNII: V5VD430YW9)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Glycerin (UNII: PDC6A3C0OX)
Methylparaben (UNII: A2I8C7HI9T)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
ALCOHOL (UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24385-777-04	128 g in 1 CAN; Type 0: Not a Combination Product	03/15/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/15/2012

Labeler - Amerisource Bergen (007914906)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(24385-777) , label(24385-777)