Antibacterial Foaming Hand Soap

Fresh Start by

Drug Labeling and Warnings

Fresh Start by is a Otc medication manufactured, distributed, or labeled by Kramer Detergents. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FRESH START- benzalkonium chloride soap 
Kramer Detergents

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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Antibacterial Foaming Hand Soap

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antibacterial

Use

For hand sanitizing to decrease bacteria on the skin

Warnings

For external use only

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

Stop use and ask a doctor if irritation or redness develops

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

Directions

Use with foaming pump or dispenser
Lather for at least 15 seconds, then rinse

Inactive ingredients

Water, Glycerin, Cocamidopropyl Betaine, Citric Acid, Anionic Surfactants.

FRESH START item #7008

FOAMING HAND SOAP

USE WITH FOAM PUMP OR DISPENSER

KILLS 99.99% OF MOST COMMON GERMS

ANTIBACTERIAL FOAMING

Distributed by Kramer Detergents Fayetteville AR 72701 / 888-280-7075

NDC: 66868-102-01 | FDA Registered NET CONTENTS: 1 GALLON (3.87 L)

FRESH START 
benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66868-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	6.04 g  in 3805.2 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	3471.25 g  in 3805.2 g
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)	176.82 g  in 3805.2 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	7.52 g  in 3805.2 g
GLYCERIN (UNII: PDC6A3C0OX)	37.22 g  in 3805.2 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	106.35 g  in 3805.2 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66868-102-01	3805.2 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/14/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	06/14/2020	11/30/2020

Labeler - Kramer Detergents (004779453)

Registrant - Kramer Detergents (004779453)

Establishment
Name	Address	ID/FEI	Business Operations
Kramer Detergents		004779453	manufacture(66868-102)

Revised: 11/2022

Document Id: ee6bb0b9-2051-7ba0-e053-2995a90a3cd2

34390-5

Set id: a80e68d0-97f9-5932-e053-2995a90abb7c

Version: 4

Effective Time: 20221126