BURN RELIEF SIGNATURE CARE- lidocaine 0.50% spray 
Better Living

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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

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

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. If swallowed, get medical help or contact a Poison Control Center immediately

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

image description

BURN RELIEF  SIGNATURE CARE
lidocaine 0.50% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-761
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-761-04127 g in 1 CAN; Type 0: Not a Combination Product03/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/30/2018
Labeler - Better Living (009137209)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(21130-761) , label(21130-761)

Revised: 1/2018
Document Id: 69211494-092e-4f25-9b90-937ab2794b6d
Set id: 399e7f75-4fd6-4515-84f2-f0e24b2984b9
Version: 1
Effective Time: 20180119
 
Better Living