Your browser does not support JavaScript! PUBLIX BURN RELIEF (LIDOCAINE HCL) GEL [PUBLIX SUPER MARKETS INC]
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PUBLIX BURN RELIEF (lidocaine hcl) gel
[Publix Super Markets Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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)
Z02975A0.jpg

PUBLIX BURN RELIEF  
lidocaine hcl gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:56062-702
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE0.5 g  in 100 g
MENTHOL (MENTHOL) MENTHOL0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
FD&C BLUE NO. 1 
DIAZOLIDINYL UREA 
EDETATE DISODIUM 
GLYCERIN 
POLYSORBATE 20 
PROPYLENE GLYCOL 
TOCOPHEROL 
TROLAMINE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-702-16454 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/15/2012
Labeler - Publix Super Markets Inc (006922009)

Revised: 11/2012
 
Publix Super Markets Inc

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