BURNRELIEF- lidocaine hcl gel

burnrelief by

Drug Labeling and Warnings

burnrelief by is a Otc medication manufactured, distributed, or labeled by Publix, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine HCl

purpose

External analgesic

Use

for the temporary relief of pain and itching associated with

• minor burns
• sunburn
• minor cuts
• scrapes
• insect bites
• minor skin irritations

warnings

For external use only

Stop use and ask a doctor if

condition worsens, or if symptoms persist for more than 7 days or clean 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

• 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

inactive ingredients

water, propylene glycol, glycerin, Aloe barbadensis leaf juice, triethanolamine, isopropyl alcohol, polysorbate 80, carbomer, diazolidinyl urea, menthol, disodium EDTA, blue 1, yellow 5

Adverse Reactions

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY

LAKELAND, FL 33811

publix.com

PUBLIX GUARANTEE: COMPLETE SATISFACTION

OR YOUR MONEY BACK

005.001/005AB

principal display panel

Publix

burnrelief

AFTER SUN ALOE

PAIN RELIEVING GEL

SUNBURN RELIEF

WITH LIDOCAINE HCl

NET WT 8 OZ (226 g)

INGREDIENTS AND APPEARANCE

BURNRELIEF 
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 56062-942
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	5.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TROLAMINE (UNII: 9O3K93S3TK)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
MENTHOL (UNII: L7T10EIP3A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-942-34	226 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/10/2017

Labeler - Publix (006922009)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		790752542	manufacture(56062-942)