Label: WOUND AND INFECTION MEDICATION- anti microbial lotion

  • NDC Code(s): 86131-201-04
  • Packager: Whitebridge Pet Brands
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 12, 2023

If you are a consumer or patient please visit this version.

  • DRUG FACTS

    Active Ingredients Purpose

    Benzalkonium Chloride 0.15%..........Antimicrobial 

  • PURPOSE

    Purpose

    Antimicrobial

  • Uses

    cleans area around wound, kills bacteria that cause infection and speeds healing

  • Warnings

    For external use on dogs only.

    Do not use

    • On dogs less than 12 weeks old
    • In eyes, over large areas of the body, in cases of deep or punctured wounds, on animal bites, or on serious burns
    • If redness, irritation, or swelling persists or increases stop use and consult a veterinarian
    • For over one week unless directed by a veterinarian. If condition persists or gets worse, consult a veterinarian
    Keep this and all pet products out of reach of children. 
  • Directions

    thoroughly cleanse affected area to remove dirt and debris. Rinse well to eliminate any soap residue. Apply lotion twice daily or as needed. Do not wash off. Continue usage until area is completely healed. Wash hands after application.

  • Other information

    avoid temperatures above 86 F

  • Drug Facts (contiuned)

    Inactive ingredients Carbomer, Cetyl Alcohol, Dimethicone, Ethylhexyl Glycerin, Glycerin USP, Glyceryl Acrylate/Acrylic Acid Copolymer, Glyceryl Stearate, Glyceryl Stearate SE, Mineral Oil, PEG-100 Stearate, Perflurodecalin (Rejuvenox), Phenoxyethanol, Propylene Glycol, Stearic Acid, Triethanolamine, Water. 

  • DESCRIPTION

    Rejuvenox oxygenates the skin layers which promotes healing.

    Rejuvenox is a registered trademark of Melan-Inc.

    DOGSWELL.COM

    Facebook.com/Dogswell 888-559-8833

  • SPL UNCLASSIFIED SECTION

    Distrubuted by Whitebridge Pet Brands,

    St. Louis, MO 63141

    2020 Whitebridge. All Rights Reserved.

    NDC# 86131-201-04

  • PRINCIPAL DISPLAY PANEL

    [Image jpeg] REMEDY RECOVERYimage description

    DOGSWELLimage description

    WOUND & INFECTION MEDICATION

    for DOGS

    TREATS INFECTIONS

    KILLS BACTERIAimage descriptionimage description

    PROMOTES HEALING

    For Minor Wounds

    or Broken Skin

    Net Contents: 118ml. (4 fl. oz.)image description

    image description

  • INGREDIENTS AND APPEARANCE
    WOUND AND INFECTION MEDICATION 
    anti microbial lotion
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86131-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.15 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PERFLUORODIMETHYLCYCLOHEXANE (UNII: Q1Y54IOL0P)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    FENOPROP TRIETHANOLAMINE (UNII: 2F3CU8K84U)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86131-201-04118 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2020
    Labeler - Whitebridge Pet Brands (138434316)
    Registrant - Whitebridge Pet Brands (138434316)
    Establishment
    NameAddressID/FEIBusiness Operations
    Westwood Laboratories LLC832280635manufacture, api manufacture