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NDC 90039-0100-00 KLEAN-75 75 mL/100mL Details

KLEAN-75 75 mL/100mL

KLEAN-75 is a TOPICAL CLOTH in the HUMAN OTC DRUG category. It is labeled and distributed by Paaneeco, Inc.. The primary component is ALCOHOL.

Product Information

NDC	90039-0100
Product ID	90039-100_74a31a29-53cc-4c7a-b578-d65568f8e84f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	KLEAN-75
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ethyl alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	CLOTH
Route	TOPICAL
Active Ingredient Strength	75
Active Ingredient Units	mL/100mL
Substance Name	ALCOHOL
Labeler Name	Paaneeco, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2023-12-31

Package

Package Images

NDC 90039-0100-00 (90039010000)

Pricing Information	N/A
NDC Package Code	90039-100-00
Billing NDC	90039010000
Package	100 PACKAGE in 1 BOX (90039-100-00) / 2.4 mL in 1 PACKAGE
Marketing Start Date	2020-07-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cad9647a-4efa-45a0-9c39-2a22cac3a189 Details

Drug Facts

Active ingredient

Ethyl alcohol 75%

Purpose

Antiseptic

Use

For hand washing to decrease bacteria on the skin.

Warnings

For external use only

Flammable. Keep away from heat or flame.

When using this product

■ keep out of eyes. In case of contact with eyes, rinse thoroughly with water

■ avoid contact with broken skin

Stop use and ask a doctor if

■ irritation and redness develop

■ condition persists for more 72 hours

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

■ not recommended for infants

Other information

Store below 43°C(110°F)

Inactive ingredients

Purified water

Questions?

408-241-8880, Paaneeco International

SPL UNCLASSIFIED SECTION

Kills germs

Good to use within 24 months of manufacturing.

Use on your hands

Manufactured by:

Paaneeco, Inc.

1285, Jangjero, Gyeyang-gu,

Incheon, South Korea

Keep cover tightly sealed to prevent from drying.

Made in South Korea

Packaging

INGREDIENTS AND APPEARANCE

KLEAN-75

ethyl alcohol cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:90039-100
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:90039-100-10	10 in 1 BOX	07/09/2020
1		2.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
2	NDC:90039-100-30	30 in 1 BOX	07/09/2020
2		2.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
3	NDC:90039-100-60	60 in 1 BOX	07/09/2020
3		2.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
4	NDC:90039-100-00	100 in 1 BOX	07/09/2020
4		2.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
5	NDC:90039-100-20	20 in 1 CARTON	12/28/2021
5		2.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
6	NDC:90039-100-70	70 in 1 CARTON	12/28/2021
6		2.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
7	NDC:90039-100-80	80 in 1 CARTON	12/28/2021
7		2.4 mL in 1 PACKAGE; Type 0: Not a Combination Product
8	NDC:90039-100-55	550 in 1 CARTON	12/28/2021
8		2.4 mL in 1 PACKAGE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/09/2020

Labeler - Paaneeco, Inc. (689196778)

Name	Address	ID/FEI	Business Operations
Establishment
Paaneeco, Inc.		689196778	manufacture(90039-100)

Revised: 12/2021

Document Id: 74a31a29-53cc-4c7a-b578-d65568f8e84f

Set id: cad9647a-4efa-45a0-9c39-2a22cac3a189

Version: 3

Effective Time: 20211230