STRAWFIELD PETS ANTI-ITCH MEDICATED WITH PRAMOXINE HYDROCHLORIDE- pramoxine hydrochloride shampoo 
NEXTMUNE AB

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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NEXTMUNE AB - ANTI-ITCH MEDICATED SHAMPOO WITH PRAMOXINE HYDROCHLORIDE (86127-102)

ACTIVE INGREDIENTS

PRAMOXINE HYDROCHLORIDE....1%

Strawfield Pets Anti Itch (Pramoxine) Shampoo, 16 oz (474 mL) - Amazon

STRAWFIELD PETS ANTI-ITCH MEDICATED  WITH PRAMOXINE HYDROCHLORIDE
pramoxine hydrochloride shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86127-102
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
WATER (UNII: 059QF0KO0R)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
OATMEAL (UNII: 8PI54V663Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86127-102-16474 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/20/2023
Labeler - NEXTMUNE AB (352950223)
Establishment
NameAddressID/FEIBusiness Operations
Custom Veterinary Services LLC619511483manufacture, api manufacture

Revised: 3/2023
Document Id: 55e14d65-94dd-4679-8128-a59d41e42246
Set id: 407d966a-0cd0-4bb1-9557-ee0df2a1e06d
Version: 1
Effective Time: 20230320
 
NEXTMUNE AB