Noromectin Pour-On For Cattle: Product Information (Page 2 of 2)

ANIMAL SAFETY

Studies conducted in the U.S.A. have demonstrated the safety margin for ivermectin. Based on plasma levels, the topically applied formulation is expected to be at least as well tolerated by breeding animals as is the subcutaneous formulation which had no effect on breeding performance.

WARNING

NOT FOR USE IN HUMANS

Keep this and all drugs out of the reach of children.

The Safety Data Sheet (SDS) contains more detailed occupational safety Information. To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Norbrook at 1-866-591-5777. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

WARNING! FLAMMABLE!

KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME, AND OTHER SOURCES OF IGNITION.

This product should not be applied to self or others because it may be irritating to human skin and eyes and absorbed through the skin. To minimize accidental skin contact, the user should wear a long-sleeved shirt and rubber gloves. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water and seek medical attention.

RESIDUE WARNING: Cattle must not be treated within 48 days of slaughter for human consumption. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

PRECAUTIONS

  • Store at or below 25°C (77°F), excursions permitted up to 40°C (104°F). Protect from light.
  • Use only in well-ventilated areas or outdoors.
  • Close container tightly when not in use.
  • Cattle should not be treated when hair or hide is wet since reduced efficacy may be experienced.
  • Do not use when rain is expected to wet cattle within six hours after treatment.
  • This product is for application to skin surface only. Do not give orally or parenterally.
  • Cloudiness in the formulation may occur when Noromectin Pour-On is stored at temperatures below 32° F. Allowing it to warm at room temperature will restore the normal appearance without affecting efficacy.
  • Antiparasitic activity of ivermectin will be impaired if the formulation is applied to areas of the skin with mange scabs or lesions, or with dermatoses or adherent materials, e.g. caked mud or manure.
  • Ivermectin has been associated with adverse reactions in sensitive dogs; therefore, Noromectin Pour-On (ivermectin topical solution) is not recommended for use in species other than cattle.

When to Treat Cattle with Grubs

Noromectin Pour-On effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. While this is not peculiar to ivermectin, destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum when it is in the esophageal tissues may cause bloat: killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either before or after these stages of grub development.

Cattle treated with Noromectin Pour-On at the end of the fly season may be re-treated with Noromectin during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian.

OTHER WARNINGS

Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers.

Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance.

Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd/flock, prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method).

A decrease in a drug’s effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.

Environmental Safety

Studies indicate that when ivermectin comes in contact with the soil, it readily and tightly binds to the soil and becomes inactive over time. Free ivermectin may adversely affect fish or certain aquatic organisms. Do not permit cattle to enter lakes, streams or ponds for at least six hours after treatment. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

As with other avermectins, ivermectin is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependent insects.

HOW SUPPLIED

Noromectin Pour-On (ivermectin topical solution) is available in a 33.8 fl oz/1L bottle with a measure-squeeze-pour-system or in an 84.5 fl oz/2.5 L or 169 oz/5 L collapsible pack, or 676 fl oz/20 L container intended for use with appropriate automatic dosing equipment.

Restricted Drug — California. Use Only as Directed.

Approved by FDA under ANADA # 200-272

Manufactured by:
Norbrook Laboratories Limited
Newry, BT35 6PU, Co. Down,

Northern Ireland

001670I04

Norbrook ®

Principal Display Panel – 5 L Carton Label

Noromectin® Pour-On

(ivermectin topical solution)
for Cattle

Contains 5 mg ivermectin / mL

Parasiticide

Kills: Roundworms, (including Brown Stomach Worm),
Lungworms, Grubs, Sucking Lice, Biting Lice, Mange Mites,
Horn Flies

Contains 200 — 550 lb doses.

Approved by FDA under ANADA # 200-272

169 fl oz (5L)

Norbrook®

Principal Display Panel – 5 L Carton Label
(click image for full-size original)

Principal Display Panel – 5 L Container Label

Noromectin® Pour-On

(ivermectin topical solution)
for Cattle

Contains 5 mg ivermectin / mL

Parasiticide

Kills:

Roundworms, (including Brown Stomach Worm),
Lungworms, Grubs, Sucking Lice, Biting Lice,
Mange Mites, Horn Flies

Manufactured by:

Norbrook Laboratories Ltd.

Newry, Co. Down, BT35 6PU, Northern Ireland

Approved by FDA under ANADA # 200-272

169 fl oz (5L)

005670L04

Norbrook®

Principal Display Panel – 5 L Container Label
(click image for full-size original)
NOROMECTIN POUR-ON FOR CATTLE
ivermectin solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:55529-007
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ivermectin (ivermectin) ivermectin 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
isopropyl myristate
trolamine
FD&C Blue No. 1
isopropyl alcohol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55529-007-06 1 CONTAINER in 1 CARTON contains a CONTAINER
1 1000 mL in 1 CONTAINER This package is contained within the CARTON (55529-007-06)
2 NDC:55529-007-07 1 CONTAINER in 1 CARTON contains a CONTAINER
2 2500 mL in 1 CONTAINER This package is contained within the CARTON (55529-007-07)
3 NDC:55529-007-08 1 CONTAINER in 1 CARTON contains a CONTAINER
3 5000 mL in 1 CONTAINER This package is contained within the CARTON (55529-007-08)
4 NDC:55529-007-09 1 CONTAINER in 1 CARTON contains a CONTAINER
4 20000 mL in 1 CONTAINER This package is contained within the CARTON (55529-007-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200272 12/01/2004
Labeler — Norbrook Laboratories Limited (214580029)
Establishment
Name Address ID/FEI Operations
Norbrook Laboratories Limited 232880554 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Norbrook Laboratories Limited 211218325 MANUFACTURE

Revised: 05/2020 Norbrook Laboratories Limited

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