Doctor Kleen Alcohol Free Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

HAND SANITIZER- benzalkonium chloride 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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Doctor Kleen Alcohol Free Hand Sanitizer

Active Ingredient(s)

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

Use

For Hand Washing to decrease bacteria on the skin.

Recommended for repeated use.

Warnings

For external use only.

When using this product keep out of eyes, if product gets into eyes, rinse eyes with water to remove. Do not inhale or ingest.

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

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

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 104 F
• May discolor some fabrics, wood finishes and plastics

Inactive ingredients

Glycerin, Citric Acid, Decyl Gucoside, Ethylhexylglycerin, Phenoxyethanol, Tetrasodium Glutamate Diacetate, Allantoin, water

Email us at info@freshtips.com

Package Label - Principal Display Panel

236 mL NDC: 58443-0338-4

HAND SANITIZER 
benzalkonium chloride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0338
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
ALLANTOIN (UNII: 344S277G0Z)
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0338-4	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2020	05/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020	05/31/2022

Labeler - Prime Enterprises (101946028)

Registrant - Prime Enterprises (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises		101946028	manufacture(58443-0338) , analysis(58443-0338) , label(58443-0338) , pack(58443-0338)

Revised: 4/2022

Document Id: dbe9c520-d5de-6beb-e053-2a95a90a274f

34390-5

Set id: a7adbae0-c499-5a96-e053-2995a90a9e0d

Version: 5

Effective Time: 20220405