PUBLIX BURN RELIEF- lidocaine hcl gel

Publix Burn Relief by

Drug Labeling and Warnings

Publix Burn Relief by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCL 0.50%

Purpose

Topical Anesthetic

Uses

• temporary relief of pain and itching
  
• helps relieve and soothes pain from sunburn, minor burns,cuts,scrapes, skin irritations and inspect bites

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

• 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: do not use, ask a doctor
  

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)

INGREDIENTS AND APPEARANCE

PUBLIX BURN RELIEF  
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-701
Route of Administration	TOPICAL

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)