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NDC 74156-0003-02 KLEEN HANDS 75 mL/100mL Details

KLEEN HANDS 75 mL/100mL

KLEEN HANDS is a TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Casey Products, LLC. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	74156-0003
Product ID	74156-003_bd9e61bd-4e58-4e38-9d8a-c932d27a279d
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	KLEEN HANDS
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SPRAY
Route	TOPICAL
Active Ingredient Strength	75
Active Ingredient Units	mL/100mL
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Casey Products, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	n/a

Package

Package Images

NDC 74156-0003-02 (74156000302)

Pricing Information	N/A
NDC Package Code	74156-003-02
Billing NDC	74156000302
Package	295 mL in 1 BOTTLE, SPRAY (74156-003-02)
Marketing Start Date	2020-04-10
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8efa7757-ca69-4427-a108-f68507a41a06 Details

Drug Facts

Active ingredient

Isopropyl Alcohol 75% v/v

Purpose

Antiseptic

Uses

Hand sanitize to help reduce bacteria that potentially can cause disease.

For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

on children less than 2 months of age
on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing

Other information

• Store between 15-30C (59-86F) • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerin, hydrogen peroxide, purified water USP

Questions or comments?

Call 1-800-700-7873 Monday - Friday (8:00 - 4:00PM Central Time)

SPL UNCLASSIFIED SECTION

ANTIBACTERIAL

UNSCENTED

DIRECTIONS: SHAKE WELL, HOLD UPRIGHT AND SPRAY INTO YOUR HANDS 3 - 4 PUMPS FOR BEST RESULTS.

Packaging

INGREDIENTS AND APPEARANCE

KLEEN HANDS

isopropyl alcohol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74156-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:74156-003-02	295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/10/2020	08/31/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/10/2020	08/31/2023

Labeler - Casey Products, LLC (080790289)

Name	Address	ID/FEI	Business Operations
Establishment
Casey Products, LLC		080790289	manufacture(74156-003)

Revised: 9/2022

Document Id: bd9e61bd-4e58-4e38-9d8a-c932d27a279d

Set id: 8efa7757-ca69-4427-a108-f68507a41a06

Version: 2

Effective Time: 20220902