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NDC 67996-0457-14 Kontakt II Hand Sanitizer 1.3 mg/mL Details

Kontakt II Hand Sanitizer 1.3 mg/mL

Kontakt II Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Select Specialty Products. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	67996-0457
Product ID	67996-457_7d9c58d2-fbf8-4d7a-9b28-3e00accaade2
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	Kontakt II 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	Select Specialty Products
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 67996-0457-14 (67996045714)

Pricing Information	N/A
NDC Package Code	67996-457-14
Billing NDC	67996045714
Package	3785 mL in 1 BOTTLE, PLASTIC (67996-457-14)
Marketing Start Date	2019-07-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e97112d1-339a-4073-be09-fe0e39ce7834 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

Kontakt II Hand Sanitizer 6457 Drug Facts and Label

INGREDIENTS AND APPEARANCE

KONTAKT II HAND SANITIZER

benzealkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67996-457
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:67996-457-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	07/02/2019
2	NDC:67996-457-18	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/02/2019
3	NDC:67996-457-14	3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/02/2019
4	NDC:67996-457-12	1000 mL in 1 BAG; Type 0: Not a Combination Product	07/02/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	07/02/2019

Labeler - Select Specialty Products (121819445)

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

Name	Address	ID/FEI	Business Operations
Establishment
ABC Compounding Co., Inc.		003284353	manufacture(67996-457)

Revised: 7/2019

Document Id: 7d9c58d2-fbf8-4d7a-9b28-3e00accaade2

Set id: e97112d1-339a-4073-be09-fe0e39ce7834

Version: 1

Effective Time: 20190702