DETER-X- pramoxine hcl ointment 
EMS ACQUISITION CORP.

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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EMS (as CMO) - Deter-X (59228-601)

ACTIVE INGREDIENT

PRAMOXINE HCL 1%

CCF08232014

DETER-X 
pramoxine hcl ointment
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:59228-601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE0.15 g  in 15 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
DIGLYCERIN (UNII: 3YC120743U)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59228-601-1515 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/02/2013
Labeler - EMS ACQUISITION CORP. (048602791)
Establishment
NameAddressID/FEIBusiness Operations
EMS ACQUISITION CORP.048602791manufacture
Establishment
NameAddressID/FEIBusiness Operations
AbbVie Inc.078521674api manufacture

Revised: 4/2022
Document Id: 025f8522-73f4-44d9-bcdd-4c45535fc612
Set id: a977d651-2b4b-4c8f-bae4-b9e9e3a2bce8
Version: 1
Effective Time: 20220422
 
EMS ACQUISITION CORP.