STRAWFIELD PETS ANTI-ITCH MEDICATED WITH PRAMOXINE HYDROCHLORIDE- pramoxine hydrochloride shampoo
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Summary of Product characteristics
(SPC)
20-03-2023
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Active ingredient:
PRAMOXINE HYDROCHLORIDE....1%
Available from:
NEXTMUNE AB
Administration route:
TOPICAL
Prescription type:
OTC
Authorization status:
unapproved drug other
Summary of Product characteristics
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 MEDICATED WITH PRAMOXINE
HYDROCHLORIDE
pramoxine hydrochloride shampoo
PRODUCT INFORMATION
PRODUCT TYPE
OTC ANIMAL DRUG
ITEM CODE (SOURCE)
NDC:86127-102
NEXTMUNE AB
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
Revised: 3/2023
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