PUBLIX BURN RELIEF ALOE VERA- 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.

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Drug Facts

Active ingredient

Lidocaine HCl   0.5%


Purpose

Topical Analgesic


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 if 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 a Poison Control Center right away


Directions

Inactive ingredients

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


Principal Display Panel

publix

burn relief

ALOEVERA GEL

COOLS AND RELIEVES

SUNBURN PAIN WITH LIDOCAINE

NET WT 8 OZ(226 g)

ZPU012A.jpg


PUBLIX BURN RELIEF  ALOE VERA
lidocaine hydrochloride gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-711
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 ANHYDROUS 0.5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
TROLAMINE (UNII: 9O3K93S3TK)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MENTHOL (UNII: L7T10EIP3A)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:56062-711-19 226 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 07/12/2013
Labeler - Publix Super Markets Inc (006922009)

Revised: 7/2013
Document Id: ee564f46-20b1-42a1-9544-18ad42c243dd
Set id: ec6d22e8-0d6e-4869-92db-1a037d8bc201
Version: 1
Effective Time: 20130712
 
Publix Super Markets Inc