Label: PUBLIX BURN RELIEF - lidocaine and menthol gel
- NDC Code(s): 56062-702-16
- 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 ingredients
- 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
Keep out of reach of children.Close
- condition worsens or symptoms persist for more than 7 days.
- symptoms clear up and occur again within a few days.
If swallowed get medical help or contact Poison Control Center immediately.
- 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. Close
- Principal Display Panel
ALOE VERA GEL
SOOTHES PAIN WITH LIDOCAINE AND MENTHOL
NET WT 16 OZ (454g)
- INGREDIENTS AND APPEARANCE
PUBLIX BURN RELIEF
lidocaine hcl gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56062-702 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56062-702-16 454 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 11/15/2012 Labeler - Publix Super Markets Inc (006922009)