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NDC 90039-0200-01 KLEAN-75 75 mL/100mL Details

KLEAN-75 75 mL/100mL

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

Product Information

NDC	90039-0200
Product ID	90039-200_630d7887-1216-42fa-9915-ff4fa316573a
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	GEL
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	2022-12-31

Package

Package Images

NDC 90039-0200-01 (90039020001)

Pricing Information	N/A
NDC Package Code	90039-200-01
Billing NDC	90039020001
Package	975 mL in 1 BOTTLE (90039-200-01)
Marketing Start Date	2020-07-09
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8a6f603d-35b8-49c4-8e50-4c3d9393f787 Details

Drug Facts

Active ingredient

Ethyl alcohol 75% v/v

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

aloe barbadensis leaf juice, carbomer, glycerin, purified water

Questions?

408-241-8880, Paaneeco International

SPL UNCLASSIFIED SECTION

Aloe Vera

• Kills germs

• Moisturizing Aloe

Good to use within 24 months of manufacturing.

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 gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:90039-200
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
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:90039-200-05	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2020
2	NDC:90039-200-01	975 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2020
3	NDC:90039-200-02	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/09/2020
4	NDC:90039-200-03	18000 mL in 1 CONTAINER; Type 0: Not a Combination Product	07/09/2020

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(90039-200)

Revised: 8/2020

Document Id: 630d7887-1216-42fa-9915-ff4fa316573a

Set id: 8a6f603d-35b8-49c4-8e50-4c3d9393f787

Version: 2

Effective Time: 20200812