Defense Zone Hand Sanitizer

Defense Zone by

Drug Labeling and Warnings

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

Drug Details [pdf]

DEFENSE ZONE HAND SANITIZER- ethyl alcohol gel 
Prime Enterprises

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 Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

• to decrease bacteria on the skin that could cause disease
• recommended for repeated use

Warnings

For external use only.

Flammable

Flammable. Keep away from heat or falme.

When using this product

• keep out of eyes. In case of contact with eyes, flush thoroughly with water
• avoid contact with broken skin.
• do not inhale or ingest.

Stop use and ask a doctor if

• irritation and redness develop
• condition persists for more than 72 hours

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

Directions

Directions

• wet hands thoroughly with product and allow to dry without wiping
• for children under 6, use only under adult supervision
• not recommended for infants

Other information

• do not store above 104ºF
• may discolor some fabrics
• harmful to wood finishes and plastics

Inactive ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Carbomer, Glycerin, Isopropyl Myristate, Tocopherol, Water

Call 1-855-548-4653

Defense Zone Hand Sanitizer

DEFENSE ZONE  HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0462
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	604.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CARBOMER 934 (UNII: Z135WT9208)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0462-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/22/2020	10/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/22/2020	10/31/2022

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(58443-0462) , analysis(58443-0462) , label(58443-0462) , pack(58443-0462)

Revised: 4/2022

Document Id: dbe93388-b7d1-224a-e053-2995a90a3b84

34390-5

Set id: d240f75d-c624-e7e5-e053-2995a90affc1

Version: 2

Effective Time: 20220405