Defense Zone Antibacterial Hand Soap Fresh Pineapple

Defense Zone by

Drug Labeling and Warnings

Defense Zone by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DEFENSE ZONE ANTIBACTERIAL- benzalkonium chloride soap 
Prime Enterprises, 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.

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Defense Zone Antibacterial Hand Soap Fresh Pineapple

Active Ingredients

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

For handwashing to decrease bacteria on the skin

Warnings

For external use only.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor

if irritation and redness develop

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands, work into a rich lather

Rinse well

For children under 6, use only under adult supervision.

Inactive ingredients

Acrylates/Beheneth-25 Methacrylate/HEMA Crosspolymer-2, Aloe Barbadensis Leaf Juice, Camellia Oleifera (Green Tea) Leaf Extract, Cetrimonium Chloride, Citric Acid, Cocamide DIPA, Ethylhexylglycerin, Fragrance, Glycerin, Lauramine Oxide, PEG-150 Distearate, Phenoxyethanol, Tetrasodium Glutamate Diacetate, Water, Yellow 5

Defense Zone Antibacterial Hand Soap Fresh Pineapple

DEFENSE ZONE  ANTIBACTERIAL
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0380
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.287 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BEHENETH-25 METHACRYLATE (UNII: 108R05PWG6)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
WATER (UNII: 059QF0KO0R)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
ACRYLIC ACID (UNII: J94PBK7X8S)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)

Product Characteristics
Color	yellow (Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0380-5	251 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	11/30/2020	11/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	11/30/2020	11/30/2022

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(58443-0380) , label(58443-0380) , analysis(58443-0380) , pack(58443-0380)

Revised: 4/2022

Document Id: dbe94e42-6755-1cbe-e053-2995a90ac3b7

34390-5

Set id: b83d2022-df06-6668-e053-2a95a90a83a0

Version: 2

Effective Time: 20220405