STRAWFIELD PETS BENZOYL PEROXIDE MEDICATED WITH PRECIPITATED SULFUR- benzoyl peroxide 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 - BENZOYL PEROXIDE MEDICATED SHAMPOO WITH PRECIPITATED SULFUR (86127-104)

ACTIVE INGREDIENTS

BENZOYL PEROXIDE GEL, USP....2.5%

PRECIPITATED SULFUR, USP....2.0%

01b LBL_Benzoyl Peroxide Medicated Shampoo (AMZ)_474mL

01b LBL_Benzoyl Peroxide Medicated Shampoo (Reg)_474mL

STRAWFIELD PETS BENZOYL PEROXIDE MEDICATED WITH PRECIPITATED SULFUR
benzoyl peroxide shampoo

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 g in 100 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:86127-104-16	474 mL in 1 BOTTLE

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

Labeler - NEXTMUNE AB (352950223)

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