BENZALKONIUM CHLORIDE- hot spot skin remedy gel

Benzalkonium Chloride by

Drug Labeling and Warnings

Benzalkonium Chloride by is a Animal medication manufactured, distributed, or labeled by Sergeants Pet Care Products LLC, Lonza Biologics Inc, Straight Arrow Products Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT:

Benzalkonium Chloride

PURPOSE

PURPOSE:  SENTRY Hot Spot Skin Remedy for dogs is formulated to be effective for skin irritations.  Specifically kills staphylococcus intermedius bacteria.  Hot spots in dogs are commonly associated with staphylococcus intermedius.  Kills topical bacteria, fungus and viruses.  SENTRY Hot Spot Skin Remedy is indicated for superficial cuts, scrapes, and abrasions.  Best of all, SENTRY Hot Spot Skin Remedy contains no alcohol and is a non-stinging formula.

Signs of Hot Spots:  Hot spots are usually accompanied by incessant rubbing, scratching and biting due to intense itching.  Other signs are moist reddened areas, hair loss, and flaky skin.  Hot spots are usually warm to the touch.

WARNINGS:

Do not use on puppies under 6 weeks of age.

For external use only on dogs.

KEEP OUT OF REACH OF CHILDREN AND PETS

DIRECTIONS FOR USE:

Trim the hair around the sore. Wash the area with mild soap and water, rinse and pat dry. Apply to affected area using the applicator tip. Does not require dabbing on with a cotton ball. Consult a veterinarian if any problems persist or are of concern.

STORAGE AND HANDLING

Store below 30°C (86°F)

INACTIVE INGREDIENTS:

Allantoin, Cetrimonium Chloride, Citric Acid, Cocamidopropyl Betain, Green 5 (Cl 61570), Hydroxypropyl Methyloellubse, Methylparaben, Octoxynol 9, Propylene Glycol, Propylparaben, Sodium Hydroxide, Triethanolamine, Water.

QUESTIONS

Questions or medical emergency: 1-800-224-7387

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BENZALKONIUM CHLORIDE 
hot spot skin remedy gel

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 21091-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)
HYPROMELLOSES (UNII: 3NXW29V3WO)
METHYLPARABEN (UNII: A2I8C7HI9T)
OCTOXYNOL 9 (UNII: 7JPC6Y25QS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	blue (blue/green)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21091-001-01	118 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/17/2022

Labeler - Sergeants Pet Care Products LLC (876995171)

Establishment
Name	Address	ID/FEI	Business Operations
Lonza Biologics Inc		093149750	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Straight Arrow Products Inc		052165154	manufacture, label, pack