BURN RELIEF PAIN RELIEVER WELL AT WALGREENS- lidocaine 0.5% spray 
Walgreens

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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Burn Relief Spray

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 and comments?

1-866-483-2846

image description

BURN RELIEF PAIN RELIEVER  WELL AT WALGREENS
lidocaine 0.5% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3107
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:0363-3107-04170 g in 1 CAN; Type 0: Not a Combination Product03/15/2013
2NDC:0363-3107-06227 g in 1 CAN; Type 0: Not a Combination Product03/15/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/15/2013
Labeler - Walgreens (008965063)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(0363-3107) , label(0363-3107)

Revised: 1/2018
Document Id: 58655bec-e62f-4387-9f24-ef1127fb2506
Set id: cc8d34f0-91e0-44b7-9fe4-4c31f7d98a8d
Version: 2
Effective Time: 20180130
 
Walgreens