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NDC 49351-0103-01 Tork Hand Sanitizer Alcohol Free Foam 0.13 g/100mL Details

Tork Hand Sanitizer Alcohol Free Foam 0.13 g/100mL

Tork Hand Sanitizer Alcohol Free Foam is a TOPICAL LIQUID 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	49351-0103
Product ID	49351-103_9b00ff37-ffca-f9cb-e053-2995a90a114d
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 Hand Sanitizer Alcohol Free Foam
Proprietary Name Suffix	n/a
Non-Proprietary Name	Benzalkonium Chloride
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
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	part333E
Listing Certified Through	2024-12-31

Package

Package Images

NDC 49351-0103-01 (49351010301)

Pricing Information	N/A
NDC Package Code	49351-103-01
Billing NDC	49351010301
Package	6 BOTTLE in 1 BOX (49351-103-01) / 1000 mL in 1 BOTTLE
Marketing Start Date	2018-10-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d2e6d469-ddcc-4cad-829f-245dc1ec8368 Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Benzalkonium chloride, 0.13%

Purpose

Antiseptic

Uses

Handwash to help reduce bacteria on the skin.

Warnings

For external use only
Do not ingest
Avoid contact with the eyes

Ask a doctor before use if you have:

Deep wounds, animal bites or serious burns

Stop use and ask a doctor:

If irritation and redness develop.

Keep out of reach of children:

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

Directions

Dispense enough to spread on both hands to wrists, then rub into the skin for at least 30 seconds. Allow to dry.

Inactive ingredients

Water/Eau/Aqua, Lactic acid, Triethanolamine, Cocoamidopropyl betaine, 2-Phenoxyethanol, Propano-1,2-diol, Sodium cocoamphoacetate.

Questions or Comments?

1-866-722-8675

PRINCIPAL DISPLAY PANEL

TORK®

Hand Sanitizer

Alcohol Free Foam

Benzalkonium Chloride, 0.13%

NDC 49351-103-01

Manufactured for Essity Professional Hygiene North America, LLC

2929 Arch Street

Philadelphia, PA 19104

www essity.com, 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 HAND SANITIZER ALCOHOL FREE FOAM

benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49351-103
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
WATER (UNII: 059QF0KO0R)
LACTIC ACID (UNII: 33X04XA5AT)
TROLAMINE (UNII: 9O3K93S3TK)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:49351-103-01	6 in 1 BOX	10/15/2018
1		1000 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	part333E	08/12/2014

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(49351-103) , label(49351-103) , pack(49351-103)

Revised: 12/2019

Document Id: 9b00ff37-ffca-f9cb-e053-2995a90a114d

Set id: d2e6d469-ddcc-4cad-829f-245dc1ec8368

Version: 3

Effective Time: 20191231

Search by Drug Name or NDC

NDC 49351-0103-01 Tork Hand Sanitizer Alcohol Free Foam 0.13 g/100mL Details

Tork Hand Sanitizer Alcohol Free Foam 0.13 g/100mL

Product Information

Package

Package Images

NDC 49351-0103-01 (49351010301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d2e6d469-ddcc-4cad-829f-245dc1ec8368 Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Ask a doctor before use if you have:

Stop use and ask a doctor:

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 49351-0103-01 Tork Hand Sanitizer Alcohol Free Foam 0.13 g/100mL Details

Tork Hand Sanitizer Alcohol Free Foam 0.13 g/100mL

Product Information

Package

Package Images

NDC 49351-0103-01 (49351010301)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL d2e6d469-ddcc-4cad-829f-245dc1ec8368 Details

SPL UNCLASSIFIED SECTION

﻿Active ingredient

﻿Purpose

﻿Uses

﻿Warnings

Ask a doctor before use if you have:

Stop use and ask a doctor:

﻿Keep out of reach of children:

﻿Directions

﻿Inactive ingredients

﻿Questions or Comments?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Active ingredient

Purpose

Uses

Warnings

Keep out of reach of children:

Directions

Inactive ingredients

Questions or Comments?