PUBLIX BURN RELIEF  - lidocaine hydrochloride gel 
Publix Super Markets Inc

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.

----------

Drug Facts

Active ingredient

Lidocaine HCL 0.50%

Purpose

Topical Anesthetic

Uses

Warnings

For external use only

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

When using this product

  • avoid contact with eyes.

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days.
  • symptoms clear up and occur again within a few days.

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

Directions

Inactive ingredients

Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Aloe Barbadensis Leaf Juice, Menthol, Disodium EDTA, Diazolidinyl Urea, Yellow 5, Blue 1.

Principal Display Panel

Publix
burnreilef
ALOE VERA GEL
COOLS AND RELIEVES
SUNBURN PAIN WITH LIDOCAINE
NET WT 8 OZ( 227g)
Z02875A0.jpg

PUBLIX BURN RELIEF  
lidocaine hcl gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-701
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL (UNII: L7T10EIP3A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:56062-701-16 227 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 11/15/2012
Labeler - Publix Super Markets Inc (006922009)

Revised: 11/2012
Document Id: 1721cec1-8510-46e5-9bfd-7a2a6fb130e9
Set id: cd3f3908-4272-4d76-8a3e-66657d17ba4c
Version: 2
Effective Time: 20121115
 
Publix Super Markets Inc