MUELLER FIRST AID ANTISEPTIC- benzalkonium chloride, lidocaine hydrochloride spray 
Mueller Sports Medicine, Inc.

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.

----------

Active Ingredients

Dosage

Warnings

Inactive Ingredients

Indications

OTC-Keep Out of Reach Children

Purpose

Display Panel

MUELLER FIRST AID ANTISEPTIC 
benzalkonium chloride, lidocaine hydrochloride spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52564-330
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2 g  in 100 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TEA TREE OIL (UNII: VIF565UC2G)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52564-330-1759 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/16/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/16/2013
Labeler - Mueller Sports Medicine, Inc. (006426316)

Revised: 3/2020
Document Id: a0fa8c52-61b9-cc2a-e053-2995a90a6180
Set id: a15fedd5-8a55-43ef-a2d9-0b4e338b1d44
Version: 2
Effective Time: 20200316
 
Mueller Sports Medicine, Inc.