PUBLIX BURN RELIEF - lidocaine hcl 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 ingredients

Lidocaine 0.50%
Menthol 0.10%

Topical Anesthetic

Uses

temporary relief of pain and itching
helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect 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, Alcohol Denat., Propylene Glycol, Glycerin, Polysorbate 20, Carbomer, Triethanolamine, Diazolidinyl Urea, Aloe Barbadensis Leaf Juice, Tocopherol, Disodium EDTA, Blue 1.

Principal Display Panel

Publix
relieving
ALOE VERA GEL
SOOTHES PAIN WITH LIDOCAINE AND MENTHOL
NET WT 16 OZ (454g)

PUBLIX BURN RELIEF
lidocaine hcl gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56062-702
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	0.5 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56062-702-16	454 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	11/15/2012

Labeler - Publix Super Markets Inc (006922009)