Label: FIRST AID ANTISEPTIC- benzalkonium 0.13%, lidocaine hcl 2.5% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 55910-781-05 - Packager: Dollar General
- Category: HUMAN OTC DRUG LABEL
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 July 6, 2018
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients Purpose
- Uses
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Warnings
For external use only
When using this product
- do not use in or near the eyes
- do not apply over large area of the body or in large quantities
- do not apply over raw surfaces or blistered areas
- Directions
- Other information
- Inactive ingredients
- Questions? 888-309-9030
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIRST AID ANTISEPTIC
benzalkonium 0.13%, lidocaine hcl 2.5% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-781 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 25 mg in 1 mL BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength Diazolidinyl Urea (UNII: H5RIZ3MPW4) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Methylparaben (UNII: A2I8C7HI9T) NONOXYNOL-9 (UNII: 48Q180SH9T) Propylene Glycol (UNII: 6DC9Q167V3) Propylparaben (UNII: Z8IX2SC1OH) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-781-05 148 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/29/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/02/2013 Labeler - Dollar General (068331990) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(55910-781) , label(55910-781)