Animal NDC 48106-1149-2 Stepsept Fb-t100

Field Name	Field Value
Animal NDC Code	48106-1149-2
Proprietary Name	Stepsept Fb-t100 What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name	Cupric Sulfate What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name	Boumatic, Llc
Product Type	Otc Animal Drug
Usage Information	Concentrated topical hoof treatmentNOT FOR HUMAN USEUSAGE DIRECTIONS AS A TOPICAL HOOF SPRAY:TREATMENT FOR COWS WITH HOOF ROT AND HAIRY HEEL WARTS:Clean hoof thoroughly. Spray to saturate entire hoof with undiluted StepSept FB-T100. Repeat treatments each milking until tissue is healthy.PREVENTION THERAPY FOR COWS WHO ARE SUSCEPTIBLE TO HOOF ROT AND HAIRY HEEL WARTS: Repeat every other day for six (6) days followed by a once a week maintenance application.USAGE DIRECTIONS FOR USE IN HOOFBATH SYSTEMS:Dilute and mix 1 gallon (4 L) of this product in 49 gallons (185 L) of water. Rinse and clean hoofbaths when solution becomes excessively contaminated.PREVENTION THERAPY FOR COWS WHO ARE SUSCEPTIBLE TO HOOF ROT AND HAIRY HEEL WARTS: Treat cows once a week.RECOMMENDATION: To increase efficacy of StepSept FB-T100, use a cleaning foot bath in conjunction with BouMatic’s StepSept PB-50, a pre-bath hoof cleaner concentrate to help maintain clean treatment solutions.Active Ingredient (Copper Sulfate Pentahydrate 16%, Phosphoric Acid 5%)Inactive Ingredients (Ethanol, Water)
Active Ingredient(s)	Cupric Sulfate Phosphoric Acid
Marketing Category	UNAPPROVED DRUG OTHER What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents

• Indications & Usage
• Precautions
• Package Label.Principal Display Panel

Indications & Usage

Concentrated topical hoof treatmentNOT FOR HUMAN USEUSAGE DIRECTIONS AS A TOPICAL HOOF SPRAY:TREATMENT FOR COWS WITH HOOF ROT AND HAIRY HEEL WARTS:Clean hoof thoroughly. Spray to saturate entire hoof with undiluted StepSept FB-T100. Repeat treatments each milking until tissue is healthy.PREVENTION THERAPY FOR COWS WHO ARE SUSCEPTIBLE TO HOOF ROT AND HAIRY HEEL WARTS: Repeat every other day for six (6) days followed by a once a week maintenance application.USAGE DIRECTIONS FOR USE IN HOOFBATH SYSTEMS:Dilute and mix 1 gallon (4 L) of this product in 49 gallons (185 L) of water. Rinse and clean hoofbaths when solution becomes excessively contaminated.PREVENTION THERAPY FOR COWS WHO ARE SUSCEPTIBLE TO HOOF ROT AND HAIRY HEEL WARTS: Treat cows once a week.RECOMMENDATION: To increase efficacy of StepSept FB-T100, use a cleaning foot bath in conjunction with BouMatic’s StepSept PB-50, a pre-bath hoof cleaner concentrate to help maintain clean treatment solutions.Active Ingredient (Copper Sulfate Pentahydrate 16%, Phosphoric Acid 5%)Inactive Ingredients (Ethanol, Water)

Precautions

DANGERKEEP OUT OF REACH OF CHILDRENFIRST AID:If in eyes: Hold eye open and rinse slowly and gently with water for 15-20 minutes. Remove contact lenses, if present after the first 5 minutes, then continue rinsing. Contact a physician immediately. If swallowed: Have person sip a glass of water if able to swallow. Do not give anything to an unconscious person. Do not induce vomiting. Contact a physician immediately. If breathing difficulty occurs: Move person to fresh air. Contact a physician immediately. If on skin: Take off contaminated clothing. Rinse skin immediately with plenty of water for 15-20 minutes. Contact a physician immediately.Have the product container or label with you when going for treatment, calling a physician, the emergency number listed on this label or MSDS, or a poison control center.HAZARD: Corrosive. Contains Phosphoric Acid. Severe eye, skin, and digestive tract irritant. May cause permanent eye damage. Contact with chlorinated compounds liberates toxic gas. Contact with alkalis generates heat.PRECAUTION: Avoid eye and skin contact. Do not breathe mist or spray. Wear impermeable gloves, safety glasses, rubber boots, rubber apron and face shield. Use only in well-ventilated area. Do not mix with alkaline or chlorinated materials.STORAGE: Store closed container in a cool, dry location away from sources of heat. If product becomes frozen, thaw and mix well before use.SEE MATERIAL SAFETY DATA SHEET

Package Label.Principal Display Panel