HALAMID- chloramine-t trihydrate powder 
Western Chemical Inc.

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HALAMID.
AQUA
CHLORAMINE-T POWDER FOR IMMERSION

FOR FRESHWATER-REARED SAMONOIDS

INDICATIONS: For the control of mortality in freshwater-reared salmonoids due to bacterial gill disease associated with Flavobacterium spp.

DIRECTIONS FOR USE: Apply HALAMID AQUA at concentrations of 12 to 20 milligrams per liter water [mg/L; equivalent to parts per million (ppm)] in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments in fish culture units.

FOR WALLEYE

INDICATIONS: For the control of mortality in walleye due to external columnaris disease associated with Flavobacterium columnare

DIRECTIONS FOR USE: Apply HALAMID AQUA at concentrations of 10 to 20 milligrams per liter water [mg/L;equivalent to parts per million (ppm)] in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments in fish culture units.

FOR FRESHWATER-REARED WARMWATER FINFISH

INDICATIONS:For the control of mortality in freshwater-reared warmwater finfish due to external columnaris disease associated with Flavobacterium columnare .

DIRECTIONS FOR USE: Apply HALAMID AQUA at a concentration of 20 milligrams per liter water [mg/L; equivalent to parts per million (ppm)] in a continuous flow water supply or as a static bath once per day for 60 minutes on consecutive or alternative days for three treatments in fish culture units.

USE CALCULATIONS

*
Correction (or conversion) factor is equal to: 3.785 L/gal/1000 mg/g
For Static Bath Treatment:
HALAMID.AQUA needed (grams)=Volume of water to be treated (gallons)XTreatment Concentration (ppm or mg/L)X0.0038 (correction factor*)*
For Constant Flow (flow-through) Treatment:
HALAMID AQUA needed (grams)=Water Flow (Gallons per minute)XTreatment Duration (minutes)XTreatment Concentration (ppm or mg/L)X0.0038 (correction factor)

DIRECTIONS FOR STATIC AND CONTINUOUS FLOW (FLOW THROUGH) TREATMENTS

  1. STATIC TREATMENT: Shut off water flow to culture unit before adding drug. Completely dissolve HALAMID AQUA in a separate container of culture water and thoroughly mix into the culture unit. The drug solution should be used immediately and not stored. End treatment by flushing system with fresh water. Resume normal flow.
  2. CONTINUOUS FLOW TREATMENT: Determine flow rate for culture unit. Pre-charge culture unit by administering the amount of drug needed for a static treatment. Meter additional drug solution into culture unit at a concentration and rate necessary to maintain the target dose in the culture unit for the duration of the treatment period (see table above for calculations).

LIMITATIONS AND CAUTIONS FOR FINFISH USE

  1. Before using this drug for the first time, you must inform the appropriate National Pollutant Discharge Elimination System (NPDES) permitting authority of your intentions and of the following information. A water quality benchmark for the protection of freshwater aquatic life has been derived by FDA. The acute benchmark is 0.13 mg/L, which is equivalent to the Secondary Maximum Concentration (one-half of the Secondary Acute Value). The NPDES authority may require an NPDES permit before you can discharge chloramine-T. The water quality benchmark concentration is not a discharge limit, but it may be used by the NPDES authority to derive one for the permit.The acute benchmark should be protective of aquatic life when the receiving water pH is at or above pH 6.5. Additional environmental information on chloramine-T and the benchmark value are available in an environmental assessment posted at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/EnvironmentAssessments/ucm300656.htm.
  2. Before conducting treatments with HALAMID AQUA, user should test the sensitivity of the finfish species and the Iife stage to the treatment concentration in a small number before treating the entire group.
  3. Walleye fingerlings may be more sensitive than walleye fry to HALAMID AQUA.
  4. Avoid feeding finfish immediately before or during exposure
  5. Additional aeration may be necessary to maintain adequate oxygenation levels during static treatments
  6. Do not use in earthen ponds or systems that cannot be flushed after treatment.
  7. If used in recirculating systems, bypass biofilter during treatment and flushing. Effects on biofilter and water quality have not been evaIuated. Ensure that drug is flushed from the system after treatment.

WITHDRAWAL PERIOD: ZERO DAYS

HUMAN WARNING

EMERGENCY FIRST AID:

INHALATION (Breathing):

INGESTION (Swallowing):

EYE CONTACT:

SKIN CONTACT:

HUMAN PRECAUTIONS:

ENVIRONMENTAL WARNING:

PHYSICAL AND CHEMICAL HAZARDS:

STORAGE:

DISPOSAL:

PACKAGE LABEL

HALAMID

AQUA

CHLORAMINE-T POWDER FOR IMMERSION

For control of mortality in freshwater-reared salmonids due to bacterial gill disease, in walleye due to external columnaris disease, in freshwater-reared warmwater finfish due to external columnaris disease

ACTIVE DRUG INGREDIENT
Chloramine-T trihydrate

GUARANTEED ANALYSIS
Chloramine-T (C7H7CINNa02S. 3H20)......98% w/w (minimum}

NET CONTENT:
55 pounds
(25 kilograms)

NADA 141-423,
approved by FDA

Keep out of reach of children

To report suspected adverse events, for technical assistance or to obtain a copy of the MSDS, contact Western Chemical at 1-800-283-5292 or 1-360-384-5898 or info@wchemical.com.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

MANUFACTURED FOR : Axcentive SARL. For information in the USA contact: Western Chemical, 1269 Lattimore Road, Ferndale, WA 98248 USA Phone: 1-800-283-5292 or 1-360-384-5898

axcentive

image of carton/container label
HALAMID 
chloramine-t trihydrate powder
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:50378-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORAMINE-T TRIHYDRATE (UNII: 4IU6VSV0EI) (CHLORAMINE-T ANHYDROUS - UNII:328AS34YM6) CHLORAMINE-T ANHYDROUS980 g  in 1 kg
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50378-015-055 kg in 1 PAIL
2NDC:50378-015-2525 kg in 1 DRUM
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA14142310/24/2014
Labeler - Western Chemical Inc. (085803500)
Establishment
NameAddressID/FEIBusiness Operations
Axcentive SARL275016769label, pack
Establishment
NameAddressID/FEIBusiness Operations
Tianjin Tiancheng Pharmaceutical Co., Ltd.547987057api manufacture, manufacture

Revised: 11/2014
Document Id: 3a1825f2-8f66-4ab7-a91a-d27f99c5e4c7
Set id: 4d163f44-f0a7-4059-9844-247563203bd7
Version: 2
Effective Time: 20141105
 
Western Chemical Inc.