Panama Jack 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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Panama Jack Hand Sanitizer

Active Ingredient(s)

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

• For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

Flammable

Flammable: Do not use near heat, flame or while smoking.

When using this product

• keep out of eyes. If product gets into eyes,rinse with water to remove. Avoid contact with broken skin. Do not inhale or ingest.

Stop use and ask a doctor if rash or irritation develops and lasts.

​

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

Directions

Directions

• Wet hands thoroughly with product and allow to dry without wiping
• for children under 6, use only under adult supervision

Other information

• Do not store above 104ºF.
• May discolor some fabrics, wood finishes and plastics.

Inactive ingredients

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

Call toll free 1-800-840-5225 www.panamajack.com

Panama Jack Hand Sanitizer

DEFENSE ZONE  HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0498
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	609 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: 58443-0498-4	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/22/2020	04/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/22/2020	04/30/2022

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(58443-0498) , analysis(58443-0498) , label(58443-0498) , pack(58443-0498)

Revised: 4/2022

Document Id: dbe9005f-90c9-4e60-e053-2a95a90a31af

34390-5

Set id: d5786a3d-2014-4a30-e053-2a95a90a2663

Version: 2

Effective Time: 20220405