Animal NDC 48106-1170-6 Bm System X

Field Name	Field Value
Animal NDC Code	48106-1170-6
Proprietary Name	Bm System X 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	Glycerin 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 EMOLLIENT ADDITIVENOT FOR HUMAN USEFOR EXTERNAL USE ONLYFOR MANUFACTURING USE ONLYUSAGE DIRECTIONS FOR ADDITION TO TEAT DIPSTo bring a 2% emollient teat dip to 5% total emollients, add 4 ounces (120 ml) of this product per 1 gallon (3.8 L) of teat dip.To bring a 2% emollient teat dip to 10% total emollients, add 11 ounces (336 ml) of this product per 1 gallon (3.8 L) of teat dip.To bring a 2% emollient teat dip to 12% total emollients, add 14 ounces (430 ml) of this product per 1 gallon (3.8 L) of teat dip.To bring a 5% emollient teat dip to 10% total emollients, add 7 ounces (210 ml) of this product per 1 gallon (3.8 L) of teat dip.To bring a 5% emollient teat dip to 12% total emollients, add 10 ounces (300 ml) of this product per 1 gallon (3.8 L) of teat dip.
Active Ingredient(s)	Glycerin
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

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

Precautions

CAUTIONKEEP OUT OF REACH OF CHILDRENNOT FOR HUMAN USEFIRST 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

Package Label.Principal Display Panel

BM System X label

Indications & Usage

CONCENTRATED EMOLLIENT ADDITIVENOT FOR HUMAN USEFOR EXTERNAL USE ONLYFOR MANUFACTURING USE ONLYUSAGE DIRECTIONS FOR ADDITION TO TEAT DIPSTo bring a 2% emollient teat dip to 5% total emollients, add 4 ounces (120 ml) of this product per 1 gallon (3.8 L) of teat dip.To bring a 2% emollient teat dip to 10% total emollients, add 11 ounces (336 ml) of this product per 1 gallon (3.8 L) of teat dip.To bring a 2% emollient teat dip to 12% total emollients, add 14 ounces (430 ml) of this product per 1 gallon (3.8 L) of teat dip.To bring a 5% emollient teat dip to 10% total emollients, add 7 ounces (210 ml) of this product per 1 gallon (3.8 L) of teat dip.To bring a 5% emollient teat dip to 12% total emollients, add 10 ounces (300 ml) of this product per 1 gallon (3.8 L) of teat dip.