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NDC 43097-0457-10 Puri-San Plus Instant Hand Sanitizer 1.3 mg/mL Details

Puri-San Plus Instant Hand Sanitizer 1.3 mg/mL

Puri-San Plus Instant Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by People's Janitorial Supply. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	43097-0457
Product ID	43097-457_42c90f07-ebf1-49d6-a2a5-67b4f79c24ab
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	Puri-San Plus Instant Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	BENZEALKONIUM 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	People's Janitorial Supply
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 43097-0457-10 (43097045710)

Pricing Information	N/A
NDC Package Code	43097-457-10
Billing NDC	43097045710
Package	1000 mL in 1 CARTRIDGE (43097-457-10)
Marketing Start Date	2019-02-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f0726bdd-9d2b-4383-af10-e2e0c5460e1e 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

Puri-San Plus Instant Hand Sanitizer

INGREDIENTS AND APPEARANCE

PURI-SAN PLUS INSTANT HAND SANITIZER

benzealkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43097-457
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:43097-457-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	02/20/2019
2	NDC:43097-457-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/20/2019
3	NDC:43097-457-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/20/2019
4	NDC:43097-457-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	02/20/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	02/20/2019

Labeler - People's Janitorial Supply (057299729)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(43097-457)

Revised: 1/2020

Document Id: 42c90f07-ebf1-49d6-a2a5-67b4f79c24ab

Set id: f0726bdd-9d2b-4383-af10-e2e0c5460e1e

Version: 2

Effective Time: 20200127