Label: ANTIBACTERIAL LIDOCAINE WOUND GEL- benzalkonium chloride, lidocaine hydrochloride gel
- NDC Code(s): 0363-1652-28
- Packager: WALGREENS
- This is a repackaged label.
- Source NDC Code(s): 59898-950
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 16, 2022
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- Official Label (Printer Friendly)
- Active ingredient (in each gram)
- Purpose
- Uses
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Warnings
For external use only
Do not use
- in the eyes
- over large areas of the body, particularly over raw surfaces or blistered areas
- longer than a week unless directed by a doctor
- Directions
- Other information
- Inactive ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ANTIBACTERIAL LIDOCAINE WOUND GEL
benzalkonium chloride, lidocaine hydrochloride gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-1652(NDC:59898-950) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS 2 g in 100 mL BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) CAPRYLYL GLYCOL (UNII: 00YIU5438U) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) CHLORPHENESIN (UNII: I670DAL4SZ) POLYSORBATE 20 (UNII: 7T1F30V5YH) PHENOXYETHANOL (UNII: HIE492ZZ3T) Product Characteristics Color white (colorless, clear translucent) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-1652-28 1 in 1 CARTON 12/05/2022 1 28 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 12/05/2022 Labeler - WALGREENS (008965063)