BIOCALM MOUSSE- pramoxine hydrochloride shampoo 
VetBiotek, Inc.

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.

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BioCalm Mousse

ACTIVE INGREDIENT: Pramoxine Hydrochloride 1%

biocalmmousse label

BIOCALM  MOUSSE
pramoxine hydrochloride shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86056-028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CERAMIDE 3 (UNII: 4370DF050B)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
SILVER (UNII: 3M4G523W1G)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86056-028-07200 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/10/201610/22/2021
Labeler - VetBiotek, Inc. (079730642)
Establishment
NameAddressID/FEIBusiness Operations
Custom Veterinary Services, Inc.619511483manufacture
Establishment
NameAddressID/FEIBusiness Operations
NetQem, LLC362973500api manufacture

Revised: 10/2021
Document Id: 634935cf-b587-490c-b8b4-edcd01f92af7
Set id: 66c82e2f-1431-4524-8adc-afa3c5e5deed
Version: 2
Effective Time: 20211022
 
VetBiotek, Inc.