Your browser does not support JavaScript! PUBLIX BURN RELIEF ALOE VERA (LIDOCAINE HYDROCHLORIDE) GEL [PUBLIX SUPER MARKETS INC]
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PUBLIX BURN RELIEF ALOE VERA (lidocaine hydrochloride) 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 ingredient

Lidocaine HCl   0.5%


Purpose

Topical Analgesic


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 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

  • adults and children 2 years of age and older: apply to affected areas 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 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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:56062-711
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
GLYCERIN 
ISOPROPYL ALCOHOL 
TROLAMINE 
POLYSORBATE 80 
ALOE VERA LEAF 
MENTHOL 
EDETATE DISODIUM 
DIAZOLIDINYL UREA 
FD&C YELLOW NO. 5 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-711-19226 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/12/2013
Labeler - Publix Super Markets Inc (006922009)

Revised: 7/2013
 
Publix Super Markets Inc

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