Label: PUBLIX BURN RELIEF ALOE VERA- lidocaine hydrochloride gel
- NDC Code(s): 56062-711-19
- Packager: Publix Super Markets Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active ingredient
Lidocaine HCl 0.5%
- temporary relief of pain and itching
- helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites
For external use only
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
- 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
COOLS AND RELIEVES
SUNBURN PAIN WITH LIDOCAINE
NET WT 8 OZ(226 g)
- INGREDIENTS AND APPEARANCE
PUBLIX BURN RELIEF ALOE VERA
lidocaine hydrochloride gel
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:56062-711 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 0.5 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:56062-711-19 226 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 07/12/2013 Labeler - Publix Super Markets Inc (006922009)