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NDC 49351-0104-01 Tork Foam Antibacterial 0.13 g/100mL Details

Tork Foam Antibacterial 0.13 g/100mL

Tork Foam Antibacterial is a TOPICAL SOAP in the HUMAN OTC DRUG category. It is labeled and distributed by Essity Professional Hygiene North America LLC. The primary component is BENZALKONIUM CHLORIDE.

Product Information

NDC	49351-0104
Product ID	49351-104_a1395cd3-9c1c-80b7-e053-2a95a90a7c8a
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	Tork Foam Antibacterial
Proprietary Name Suffix	n/a
Non-Proprietary Name	benzalkonium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOAP
Route	TOPICAL
Active Ingredient Strength	0.13
Active Ingredient Units	g/100mL
Substance Name	BENZALKONIUM CHLORIDE
Labeler Name	Essity Professional Hygiene North America LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49351-0104-01 (49351010401)

Pricing Information	N/A
NDC Package Code	49351-104-01
Billing NDC	49351010401
Package	1000 mL in 1 BOTTLE (49351-104-01)
Marketing Start Date	2017-03-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 45416b88-3703-4934-9439-9f2323342744 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium chloride, 0.13%

Purpose

Antiseptic

Uses

For hand washing to decrease bacteria on the skin
Recommended for repeated use

Warnings

For external use only

When using this

product avoid contact with eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if

irritation or redness develops, or if condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions

Pump a small amount of foam into palm of hand
Rub thoroughly over all surfaces of both hands for 15 seconds
Rinse with potable water

Inactive ingredients

Water/Eau/Aqua, Coco-glucoside, Laurtrimonium Chloride, Cocamidopropylamine Oxide, Citric acid.

Questions or Comments?

1-866-722-8675

PRINCIPAL DISPLAY PANEL

TORK®

Foam Soap

Antibacterial

NDC 49351-104-01

Manufactured for Essity Professional Hygiene North America, LLC

2929 Arch Street

Philadelphia, PA 19104

www.torkusa.com

For Commercial use

Made in Mexico

Premium

1 L

(33.8 US fl. oz.)

(35.2 oz. liq.)

INGREDIENTS AND APPEARANCE

TORK FOAM ANTIBACTERIAL

benzalkonium chloride soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49351-104
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
COCO GLUCOSIDE (UNII: ICS790225B)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49351-104-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/15/2017
2	NDC:49351-104-02	24 in 1 BOX	03/15/2017
2		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	03/15/2017

Labeler - Essity Professional Hygiene North America LLC (005694349)

Registrant - CYAN Labs S.A. de C.V. (812754130)

Name	Address	ID/FEI	Business Operations
Establishment
CYAN Labs S.A. de C.V.		812754130	manufacture(49351-104) , label(49351-104) , pack(49351-104)

Revised: 3/2020

Document Id: a1395cd3-9c1c-80b7-e053-2a95a90a7c8a

Set id: 45416b88-3703-4934-9439-9f2323342744

Version: 6

Effective Time: 20200319

Search by Drug Name or NDC

NDC 49351-0104-01 Tork Foam Antibacterial 0.13 g/100mL Details

Tork Foam Antibacterial 0.13 g/100mL

Product Information

Package

Package Images

NDC 49351-0104-01 (49351010401)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 45416b88-3703-4934-9439-9f2323342744 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

When using this

Stop use and ask a doctor if

Keep out of reach of children.

Directions

Inactive ingredients

Questions or Comments?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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Search by Drug Name or NDC

NDC 49351-0104-01 Tork Foam Antibacterial 0.13 g/100mL Details

Tork Foam Antibacterial 0.13 g/100mL

Product Information

Package

Package Images

NDC 49351-0104-01 (49351010401)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 45416b88-3703-4934-9439-9f2323342744 Details

SPL UNCLASSIFIED SECTION

﻿Active ingredient

﻿Purpose

﻿Uses

﻿Warnings

When using this

Stop use and ask a doctor if

Keep out of reach of children.

﻿Directions

﻿Inactive ingredients

﻿Questions or Comments?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Active ingredient

Purpose

Uses

Warnings

Directions

Inactive ingredients

Questions or Comments?