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NDC 50254-0457-27 Clean Hands Instant Hand Sanitizer 1.3 mg/mL Details

Clean Hands Instant Hand Sanitizer 1.3 mg/mL

Clean Hands Instant Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Beaver Research Company. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	50254-0457
Product ID	50254-457_8855e412-c1a4-40c1-969a-e9a2c80c7a55
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	Clean Hands Instant Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZALKONIUM CHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	1.3
Active Ingredient Units	mg/mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Beaver Research Company
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 50254-0457-27 (50254045727)

Pricing Information	N/A
NDC Package Code	50254-457-27
Billing NDC	50254045727
Package	800 mL in 1 CARTRIDGE (50254-457-27)
Marketing Start Date	2020-01-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 653a8f55-4a19-4727-97ae-f312618121d2 Details

Drug Facts Box OTC-Active Ingredient Section

benzalkonium chloride USP 0.13%

Drug Facts Box OTC-Indications & Usage Section

For hand-washing to decrease bacteria on the skin, only when water is not available

Drug Facts Box OTC-Warnings Section

For external use only

Drug Facts Box OTC-Purpose Section

Antiseptic

Drug Facts Box-OTC When Using Section

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box-OTC Stop Use Section

irritation and redness develop

Drug Facts Box-OTC Keep Out Of Reach Of Children Section

If swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box-OTC Dosage & Administration Section

press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

rub hands together until dry

wash hands with soap and water at earliest opportunity

Drug Facts Box-OTC Inactive Ingredient Section

water, glycerine, dimethicone, DMDM hydantoin, iodopropynl butylcarbamate, methylchloroisothiazolinone, methylisothiazolinone, fragrance

Quick Defense Instant Hand Sanitizer

INGREDIENTS AND APPEARANCE

CLEAN HANDS INSTANT HAND SANITIZER

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50254-457
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50254-457-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/07/2020
2	NDC:50254-457-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	01/07/2020
3	NDC:50254-457-13	800 mL in 1 BAG; Type 0: Not a Combination Product	01/07/2020
4	NDC:50254-457-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2020
5	NDC:50254-457-27	800 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	01/07/2020
6	NDC:50254-457-17	532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/07/2020

Labeler - Beaver Research Company (044960466)

Registrant - ABC Compounding Co., Inc. (003284353)

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(50254-457)

Revised: 1/2020

Document Id: 8855e412-c1a4-40c1-969a-e9a2c80c7a55

Set id: 653a8f55-4a19-4727-97ae-f312618121d2

Version: 1

Effective Time: 20200107