BURN RELIEF SIGNATURE CARE- lidocaine 0.50% spray

Burn Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                           Purpose
Lidocaine 0.5%.............................................................Topical anesthetic

PURPOSE

INDICATIONS & USAGE

Uses
For temporary relief of pain associated with pain or itching due to : minor burns, sunburns, minor cuts, insect bites, skin irritation

WARNINGS

Warnings
For external use only.

Flammable: Do not use while smoking or near heat or flame
When using this product use only as directed avoid contact with eyes

Do not puncture or incenerate. Contents under pressure. Do not store at temperature above 120F
Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within
a few days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

Directions
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.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BURN RELIEF  SIGNATURE CARE
lidocaine 0.50% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-761
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 VERA LEAF (UNII: ZY81Z83H0X)
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: 21130-761-04	127 g in 1 CAN; Type 0: Not a Combination Product	03/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/30/2018

Labeler - Better Living (009137209)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(21130-761) , label(21130-761)