STEPSEPT PH DOWN- organic salt liquid

StepSept pH Down by

Drug Labeling and Warnings

StepSept pH Down by is a Animal medication manufactured, distributed, or labeled by BouMatic, LLC, Knapp Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

STEPSEPT PH DOWN 
organic salt liquid

Product 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