Benzalkonium Chloride: Product Information

BENZALKONIUM CHLORIDE- benzalkonium chloride gel
Sergeants Pet Care Products LLC

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.

ACTIVE INGREDIENT:

Benzalkonium Chloride

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.

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 or medical emergency: 1-800-224-7387

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BENZALKONIUM CHLORIDE
hot spot skin remedy gel
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:21091-001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 118 mL
Inactive Ingredients
Ingredient Name Strength
ALLANTOIN
CETRIMONIUM CHLORIDE
CITRIC ACID MONOHYDRATE
COCAMIDOPROPYL BETAINE
D&C GREEN NO. 5
HYPROMELLOSES
METHYLPARABEN
OCTOXYNOL 9
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM HYDROXIDE
TROLAMINE
WATER
Product Characteristics
Color blue (blue/green) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21091-001-01 118 mL in 1 BOTTLE, PLASTIC None
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 Operations
Lonza Biologics Inc 093149750 api manufacture
Establishment
Name Address ID/FEI Operations
Straight Arrow Products Inc 052165154 manufacture, label, pack

Revised: 06/2022 Sergeants Pet Care Products LLC

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