Gladiator PrepMax Base: Product Information

GLADIATOR PREPMAX BASE- sodium chlorite liquid
BouMatic, LLC

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.

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 except as directed.

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

Helps reduce the spread of organisms which may cause Mastitis

USE DIRECTIONS

NOT FOR HUMAN USE

FOR EXTERNAL USE ONLY

Do not mix with any chemicals other than GLADIATOR™ PREPMAX ACTIVATOR, and water.

In a well-ventilated area, mix 1 part GLADIATOR PREPMAX BASE and 1 part GLADIATOR PREPMAX ACTIVATOR and 20 parts water. Do not mix more product than will be used in 24-hours.

PRE-DIPPING:

Before milking, dip or spray entire teat with the mixed product. Wipe teats dry after application using single-service towels to avoid cross contamination.

GLADIATOR PREPMAX BASE sodium chlorite pre dip liquid

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:48106-2031 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORITE (CHLORITE ION) SODIUM CHLORITE 74 g in 10 L

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:48106-2031-1 18.9 L in 1 DRUM None 2 NDC:48106-2031-2 56.8 L in 1 DRUM None 3 NDC:48106-2031-3 208 L in 1 DRUM None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/17/2017

Labeler — BouMatic, LLC (124727400)

Registrant — BouMatic, LLC (124727400)

Establishment
Name	Address	ID/FEI	Operations
boumatic		080073197	manufacture, api manufacture

Revised: 05/2017 BouMatic, LLC