Label: STEPSEPT PH DOWN- organic salt liquid
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NDC Code(s):
48106-1201-1,
48106-1201-2,
48106-1201-3,
48106-1201-4, view more48106-1201-5, 48106-1201-6
- Packager: BouMatic, LLC
- 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 June 1, 2014
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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INDICATIONS & USAGE
CONCENTRATED FOOTBATH ENHANCER
FOR EXTERNAL USE ONLY
USAGE DIRECTIONS FOR USE IN FOOTBATH SYSTEMS
Dilute and mix 0.5 gallon (1.9 L) of this product with half the normal amount of footbath additive. Dilute to 50 gallons (189.3 L) with water. For example: 0.5 gallon (1.9 L) of this product plus 25 pounds (11.34 Kg) of copper sulfate diluted to 50 gallons (189.3 L) with water is equal to 50 pounds (22.68 Kg) of sulfate diluted to 50 gallons (189.3 L) with water. Rinse and clean footbaths when solution becomes excessively contaminated.
TREATMENT FOR COWS WITH INTERSTITIAL DERMATITIS (FOOT ROT) AND DIGITAL DERMATITIS (HAIRY HEEL WARTS):
Treat cows every day for 5 consecutive days. Continue once a day treatment until improvement if severe foot rot or heel warts persist.
PREVENTION THERAPY FOR COWS WHO ARE SUSCEPTIBLE TO INTERSTITIAL DERMATITIS (FOOT ROT) AND DIGITAL DERMATITIS (HAIRY HEEL WARTS):
Treat cows once a week.
RECOMMENDATION:
To increase efficacy of StepSept pH-Down, use a cleaning footbath in conjunction with Bou-Matic’s StepSept PB-50, a pre-bath hoof cleaner concentrate to help maintain clean treatment solutions.
Active Ingredients: Urea Sulfate 85.6%
Inactive Ingredients: Water
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PRECAUTIONS
CAUTION
KEEP OUT OF REACH OF CHILDREN
NOT FOR HUMAN USE
FIRST 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 with soap and water. If irritation develops and persists, contact a physician.
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.
PRECAUTION: Avoid eye contact. Do not ingest. Do not mix with any chemicals.
STORAGE: Store in a closed container away from sources of heat. If product becomes frozen, thaw and mix well before use.
SEE MATERIAL SAFETY DATA SHEET
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
STEPSEPT PH DOWN
organic salt liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:48106-1201 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA SULFATE (UNII: 087CN75V0L) (UREA - UNII:8W8T17847W) UREA SULFATE 856 mg in 1 L Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:48106-1201-1 3.8 L in 1 DRUM 2 NDC:48106-1201-2 18.9 L in 1 DRUM 3 NDC:48106-1201-3 56.8 L in 1 DRUM 4 NDC:48106-1201-4 114 L in 1 DRUM 5 NDC:48106-1201-5 208 L in 1 DRUM 6 NDC:48106-1201-6 1040 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2014 Labeler - BouMatic, LLC (124727400) Registrant - BouMatic, LLC (124727400) Establishment Name Address ID/FEI Business Operations BouMatic, LLC 124727400 manufacture, api manufacture Establishment Name Address ID/FEI Business Operations Knapp Manufacturing 063012827 manufacture, api manufacture