Label: FIRST AID GNP- benzalkonium cl 0.13% lidocaine hl 2.5% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 46122-656-25 - Packager: Amerisource Bergen
- 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 January 17, 2022
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- Active ingredients Purpose
- PURPOSE
- Uses
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Warnings
For external use only
Ask a doctor before use if you have: deep or puncture wounds, animal bites, serious burns
When using this product • do not use in or near the eyes
• do not apply over large areas of the body or in large quantities
• do not apply over raw surtaces or blistered areas
Stop use and ask a doctor if • condition worsens
• symptoms persist for more than 7 days, or clear up and occur
again within a few days.
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIRST AID GNP
benzalkonium cl 0.13% lidocaine hl 2.5% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-656 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g in 100 mL LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) NONOXYNOL-9 (UNII: 48Q180SH9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-656-25 148 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/14/2021 Labeler - Amerisource Bergen (007914906) Registrant - Inspec Solutions LLC (081030372) Establishment Name Address ID/FEI Business Operations Inspec Solutions LLC 081030372 manufacture(46122-656)