Label: 35% PEROX-AID- hydrogen peroxide solution

  • NDC Code(s): 50378-014-01, 50378-014-10, 50378-014-99
  • Packager: Western Chemical Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated July 21, 2020

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

  • INSTRUCTIONS FOR USE

    USES
    FOR FRESHWATER-REARED FINFISH EGGS
    For the control of mortality in freshwater-reared finfish eggs due to saprolegniasis (fungi of the family Saprolegniaceae).
    FOR FRESHWATER-REARED COLDWATER FINFISH
    For the control of mortality in freshwater-reared coldwater finfish (all life stages) due to saprolegniasis associated with the fungi in the family Saprolegniaceae.
    FOR FRESHWATER-REARED SALMONIDS
    For the control of mortality in freshwater-reared salmonids due to bacterial gill disease associated with Flavobacterium branchiophilum.
    For the treatment and control of Gyrodactylus spp. in freshwater-reared salmonids.

    FOR FRESHWATER-REARED COOLWATER FINFISH
    For the control of mortality in freshwater-reared coolwater finfish due to external columnaris disease associated with Flavobacterium
    columnare.
    For the control of mortality in freshwater-reared coolwater finfish fingerlings and adults due to saprolegniasis associated with the fungi in the family Saprolegniaceae.
    FOR FRESHWATER-REARED WARMWATER FINFISH
    For the control of mortality in freshwater-reared warmwater finfish due to external columnaris disease associated with Flavobacterium columnare.
    For the control of mortality in freshwater-reared warmwater finfish fingerlings and adults due to saprolegniasis associated with the fungi in the family Saprolegniaceae.

  • DESCRIPTION

    DESCRIPTION
    35% PEROX-AID® (hydrogen peroxide) is a concentrated immersion solution containing 396.1 mg hydrogen peroxide per mL.

    Hydrogen Peroxide (H2O2) …………………………………….. 35% (W/W)

    Water and inert ingredients ……………………………………. 65% (W/W)

  • SPL UNCLASSIFIED SECTION

    WITHDRAWAL PERIODS
    No withdrawal period is required when used according to labeling.

  • USER SAFETY WARNINGS

    USER SAFETY WARNINGS
    Not for use in humans. Keep out of reach of children.
    INHALATION (Breathing):

    Avoid breathing vapor or mist; causes irritation of the nose, throat and lungs; exposure may be fatal.

    INGESTION (Swallowing):

    Do not swallow; this product is harmful if swallowed; large exposures may be fatal; can burn mouth, throat, and stomach.

    EYE CONTACT:

    Do not get in eyes; causes eye burns and possible blindness; effects may be delayed.

    SKIN CONTACT:

    Avoid contact with skin; causes skin irritation or burns.

  • SPL UNCLASSIFIED SECTION

  • SPL UNCLASSIFIED SECTION

    HUMAN PRECAUTIONS 

     Wear chemical safety goggles.
     Wear neoprene, butyl, or vinyl gloves.
     Keep out of reach of children.
     Use only in adequate ventilation.
     Keep containers tightly closed when not in use.
     Wear suitable protective clothing.

  • SPL UNCLASSIFIED SECTION

    EMERGENCY FIRST AID 

    In case of contact, immediately flush eyes or skin with plenty of water for at least 15 minutes. Call a physician.

     Remove and wash contaminated clothing and shoes promptly and thoroughly.
     If inhaled, move to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Call a physician.
     If swallowed, do not induce vomiting. Give large quantities of water. Never give anything by mouth to an unconscious person. Call a physician.
     Bring the package insert with you to the health care professional.

  • SPL UNCLASSIFIED SECTION

    ENVIRONMENTAL WARNINGS
    Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans or other waters unless in accordance with the require-ments of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authorities are notified in writing prior to discharge. Notify the NPDES authority that a water quality benchmark for the protection of freshwater aquatic life has been derived for hydrogen peroxide by FDA following EPA guidelines. The acute benchmark value for hydrogen peroxide is 0.7 mg/L. Water quality benchmark concentrations are not discharge limits, but may be used by the NPDES authority to derive such limits for the permit. Additional environmental information on hydrogen peroxide and the benchmark value are available in an environmental assessment available at https://animaldrugsatfda.fda.gov/adafda/app/search/public/document/down-loadEA/123.

    Mixtures with combustible or flammable materials may ignite easily, burn fiercely, or may explode in contaminated closed containers.
    When placed in an unsuitable container, or introduced to other contaminants, elevated temperatures above 38oC (100oF) can increase the decomposition rate of the product.

     In case of fire involving this product, use water only.
     Heat or contamination may cause decomposition and result in dangerous pressure

    In case of spill or leak, flush away by flooding with water applied quickly to entire spill or leak 

  • SPL UNCLASSIFIED SECTION

    DIRECTIONS

    1. Dissolve 35% PEROX-AID® in culture water before addition to the culture unit to achieve required dose based on active ingredient. Consider using aeration to help disperse the chemical and to ensure adequate oxygenation levels.
    2. Before treatment, remove dead eggs or finfish and clean rearing units to be treated.

    The formula to determine the correct volume of 35% PEROX-AID® required for treatment is:

    Treatment conc. mg/L (as H2O2)____ X treatment vol. (L) x 1,000 mL/L = ml of 35% PEROX-AID®

    396,100 mg H2O2 / L 35% PEROX-AID®

    1. FRESHWATER-REARED FINFISH EGGS
    Apply 35% PEROX-AID® at the full concentration in the table below in continuous flow water supply of finfish egg incubation units for 15 minutes. Treat finfish egg incubation units once per day on consecutive or alternate days until hatch to control mortalities associated with external saprolegniasis in a tiered dosing system as follows:

     USE     SPECIES/CLASS DOSE (AS H2O2) DURATION (per day)
     For the control of mortality due to saprolegniasis associated with fungi in the family Saprolegniaceae All cold and coolwater freshwater-reared finfish eggs1 500-1,000 mg/L 15 minutes
     750-1,000 mg/L 15 minutes

    1 An initial bioassay on a small number is recommended before treating the entire group. The amount of 35% PEROX-AID® required for treatment is dependent on the volume of water treated (which equals the water flow rate times 15 min; 10 L/min x 15 = 150L).
    Example calculation:
    500 mg/L (as H2O2) X 150L x 1,000 mL/L = 189 mL 35% PEROX-AID® 396,100 mg H2O2 /L 35% PEROX-AID®


    2. FRESHWATER-REARED FINFISH
    Apply 35% PEROX-AID® at the full concentration in the table (milligrams hydrogen peroxide per liter of culture water [mg/L; equivalent to parts per million (ppm)]) in continuous flow water supply or as a static bath in finfish culture units once per day on alternate days for three treatments.

     USE SPECIES CLASS DOSE (AS H2O2)DURATION PER DAY
     For the control of mortality due to saprolegniasis associated with fungi in the family Saprolegniaceae In freshwater-reared coldwater finfish including salmonids (all life stages) 75 mg/L60 minutes
     In freshwater-reared coolwater finfish fingerling and adults
     In freshwater-reared warmwater finfish fingerling and adults
    For the control of mortality due to bacterial gill disease associated with Flavobacterium branchiophilumIn freshwater-reared salmonids

    100 mg/L

    or 50-100 mg/L

    30 minutes

    or 60 minutes

    For the treatment and control of Gyrodactylus sppIn freshwater-reared salmonids

    100 mg/L

    50 mg/L

    30 minutes

    or 60 minutes 

    For the control of mortality due to external columnaris disease associated with Flavobacterium columnare

    In freshwater-reared coolwater and warmwater finfish fingerling and adults

    In freshwater-reared coolwater finfish fry and warmwater finfish fry

    50 mg/L

    60 minutes 

    HOW SUPPLIED


    35% PEROX-AID® is available as: 5-gallon container (19L), 55-gallon drum (208L), and 328-gallon container (1240L).

  • STORAGE, HANDLING

     Avoid outdoor storage.
     Store in original container in dry location.
     Keep out of sun and away from heat.
     Never use pressure to empty – container is not a pressure vessel.
     Keep open lights, fire, and sparks away from container.
     Do not add any other products to this container.
     Never return unused 35% PEROX-AID® to the container – dilute with plenty of water and discard.
     When empty, rinse container thoroughly with clean water before discarding.

    NOTICE: Since empty containers retain product residue, follow label warnings even after container is empty.
    Store in a manner designed to prevent spills to surface waters. Implement procedures to properly contain, clean, and dispose of any spilled material.
    Hydrogen peroxide is a strong oxidizer and a characteristic, hazardous waste as defined by RCRA (40 CFR 261). Contact your State Environmental Control Agency or the Hazardous Waste Representative at the nearest EPA Regional Office for guidance on disposal.
    DO NOT flush to sewer unless diluted to 1% or less concentration due to explosion hazard. Do not contaminate surface water when disposing of equipment washwaters or rinsate. Empty containers may contain residues and should be washed with water prior to disposal.

  • QUESTIONS/COMMENTS

    QUESTIONS/COMMENTS
    For Chemical Emergency, Spill, Leak, Fire, Exposure or Accident, CALL CHEMTREC, DAY OR NIGHT 1-800-424-9300.
    To report side effects or for technical assistance, or to obtain a copy of the SDS, contact Syndel at 1-800-283-5292 or www.syndel.com. For additional information about reporting side effects for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae.

  • Perox-Aid Label 328 gallons ver. 062519.jpg

    Perox-Aid Label 328 gallons ver. 062519.jpg

  • INGREDIENTS AND APPEARANCE
    35% PEROX-AID 
    hydrogen peroxide solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:50378-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE350 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50378-014-01208 L in 1 DRUM
    2NDC:50378-014-1019 L in 1 CONTAINER
    3NDC:50378-014-991200 L in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14125501/11/2007
    Labeler - Western Chemical Inc. (085803500)
    Registrant - Western Chemical Inc. (085803500)
    Establishment
    NameAddressID/FEIBusiness Operations
    Western Chemical Inc.085803500analysis, label