OTC Medication Information: BZK Agent Sanitizer

BZK AGENT SANITIZER- benzalkonium chloride spray
Tropical Enterprises International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient: Benzalkonium Chloride 0.13%

Stop use and ask a doctor if irritation or redness develops and persists.

Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center right away.

Uses: For hand sanitizing to decrease bacteria on the skin. Recommended for repeat use.

Questions: 1-800-535-5053

Stop use and ask a doctor if irritation or redness develops and persists.

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Uses: For hand sanitizing to decrease bacteria on the skin. Recommended for repeated use.

Directions: Wet hands thoroughly with product and allow to dry without wiping.

Inactive Ingredients: Water, 2-Phenoxyethanol, Silicon Quaternary Ammonia Salt .75%

WARNINGS For external use only

When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

Other info: Non-staining, may discolor certain fabrics.

Uses: For hand sanitizing to decrease bacteria on the skin. Recommended for repeat use.

Directions: Wet hands thoroughly with product and allow to dry without wiping.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
(click image for full-size original)

BZK AGENT SANITIZER
non alcohol spray sanitizer with additive spray
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58418-759
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 30 mL
Inactive Ingredients
Ingredient Name Strength
OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE
PHENOXYETHANOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58418-759-08 240 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 07/01/2020
Labeler — Tropical Enterprises International, Inc. (091986179)
Registrant — Tropical Enterprises International, Inc. (091986179)
Establishment
Name Address ID/FEI Operations
Tropical Enterprises International, Inc. 091986179 manufacture (58418-759), pack (58418-759), label (58418-759)

Revised: 12/2020 Tropical Enterprises International, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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