ALOE BURN RELIEF- lidocaine 0.5% spray 
DZA Brand

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%                               External analgesic

Uses

Temporarily relieves pain and itching due to

• sunburn • minor burns • minor cuts • scrapes

• insect bites • minor skin irritation

Warnings

For external use only

Flammable: Do not spray while smoking or near heat or flame

Do not use in large quantities, particulary over raw surfaces or blistered areas.

When using this product

  • keep out of your eyes
  • use only as directed
  • do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120F.

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last more than 7 days
  • symptoms clear up and occur again within a few days

Keep out of reach of the children

If swallowed, get medical help or contact a Poison Control Center right away

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 ingredients

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

Questions? 1-866-322-2439

image description

ALOE BURN RELIEF 
lidocaine 0.5% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-777
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:55316-777-04127 g in 1 CAN; Type 0: Not a Combination Product10/10/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/10/2011
Labeler - DZA Brand (090322194)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(55316-777) , label(55316-777)

Revised: 7/2018
Document Id: f31882d0-5797-4c66-936b-bb89e651372e
Set id: bf352da4-0899-4ff9-805f-e1b1c1f046cb
Version: 1
Effective Time: 20180723
 
DZA Brand