BouMatic Syst X Premium: Product Information

BOUMATIC SYST X PREMIUM- glycerin 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.

Precautions & Hazards

NOT FOR HUMAN USE
FOR EXTERNAL USE ONLY
FOR MANUFACTURING USE ONLY

General Storage

Store in a closed container away from sources of heat. If product becomes frozen, thaw and mix well before use.

Use Directions

Consult your BouMatic representative
for specific use instructions and
recommended dispensing equipment.

BouMatic Syst X Premium

BouMatic Syst X Premium

BouMatic Syst X Premium
(click image for full-size original)
BOUMATIC SYST X PREMIUM
glycerin liquid
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:48106-2037
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCERIN (GLYCERIN) GLYCERIN 50 g in 100 g
Inactive Ingredients
Ingredient Name Strength
SORBITOL SOLUTION 70% 20 g in 100 g
PEG-75 LANOLIN 20 g in 100 g
water 10 g in 100 g
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:48106-2037-1 4529 g in 1 JUG None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/03/2021
Labeler — BOUMATIC, LLC (124727400)
Establishment
Name Address ID/FEI Operations
BOUMATIC, LLC 124727400 api manufacture

Revised: 04/2021 BOUMATIC, LLC

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