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

STRAWFIELD PETS ANTI-ITCH MEDICATED by

Drug Labeling and Warnings

STRAWFIELD PETS ANTI-ITCH MEDICATED by is a Animal medication manufactured, distributed, or labeled by NEXTMUNE AB, Custom Veterinary Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

PRAMOXINE HYDROCHLORIDE....1%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86127-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86127-102-16	474 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/20/2023

Labeler - NEXTMUNE AB (352950223)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Veterinary Services LLC		619511483	manufacture, api manufacture