SILVET P- pramoxine hydrochloride shampoo 
Henry Schein

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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CUSTOM VET SERVICES - SilVet P (11695-1458), DELIST

ACTIVE INGREDIENT: Pramoxine Hydrochloride 1%

SilVetP-label

SILVET P 
pramoxine hydrochloride shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-1458
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE2.37 mg  in 237 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
CERAMIDE 3 (UNII: 4370DF050B)  
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-1458-11 in 1 BOX
1237 mL in 1 BOTTLE, PLASTIC
2NDC:11695-1458-21 in 1 BOX
2437 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/30/201705/18/2022
Labeler - Henry Schein (603750329)
Registrant - Vetbiotek (079730642)
Establishment
NameAddressID/FEIBusiness Operations
American Pharmaceuticals and Cosmetics, Inc.038023805manufacture
Establishment
NameAddressID/FEIBusiness Operations
Syn-Tech Chem. & Pharm. Co., Ltd.656002532api manufacture

Revised: 5/2022
Document Id: 6d39f30a-c1ae-42bd-bfe3-18faf251d0a9
Set id: dc1166af-f536-4bc9-8b03-f8bd2e392a15
Version: 2
Effective Time: 20220518
 
Henry Schein